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Abbott Diagnostics

Abbott Diagnostics

Abbott Diagnostics provides medical diagnostic instruments, tests, automation and informatics solutions, including clinical chemistry and immunoassay analyzers and hematology solutions. The company’s offerings are ideal for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics.
Products Covid-19Summary
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Covid-19 Abbott Diagnostics

Clinical Laboratory

Molecular Diagnostics System
ID NOW

The ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases and uses isothermal nucleic acid amplification technology for providing molecular results in minutes. The intuitively designed instrument features a large visual touchscreen for displaying the results, eliminating transcription errors and the need for printing, while its small footprint saves bench space for use in any healthcare setting.
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COVID-19 Antigen Test
BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card rapid antigen test, which has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA), offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19. The BinaxNOW test can be displayed on Abbott’s new optional app - available at no charge - for iPhone and Android devices called NAVICA. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.
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COVID-19 Antigen Test
Panbio COVID-19 Ag Rapid Test Device

The Panbio COVID-19 Ag Rapid Test Device is intended for patients suspected of current COVID-19 infection and identifies potentially contagious patients in 15 minutes. Using patient-friendly nasal or nasopharyngeal sample collection types, the high performance rapid test enables immediate treatment or isolation measures to minimize transmission. The product is not available in all countries and available in select markets.
More details

COVID-19 Anitibody Test
Panbio COVID-19 IgG/IgM Rapid Test Device

The Panbio COVID-19 IgG/IgM Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood. The test provides preliminary test results within 10-20 minutes and is not intended to be used as a donor screening test for SARS-CoV-2. The product is not available in all countries and available in select markets.
More details

COVID-19 Test
ID NOW COVID-19

The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. The easy to use ID NOW platform is designed for near-patient, point-of-care use in a variety of healthcare settings.
More details

SARS-CoV-2 Antibody Test
Panbio SARS-CoV-2 IgG ELISA

The Panbio SARS-CoV-2 IgG ELISA is an antibody test that helps identify individuals with immune response to SARS-CoV-2 and enables greater access for broad population surveillance. The test is compatible with manual ELISA, and is adaptable to semi-automated and fully-automated equipment, enabling easy deployment within a lab's existing infrastructure. The product is not available in all countries and available in select markets.
More details

SARS-CoV-2 IgG Immunoassay
SARS-CoV-2 IgG II Quant

The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Alinity and ARCHITECT i Systems. The assay is to be used as an aid in the diagnosis of SARS-CoV-2 infection in conjunction with clinical presentation and other laboratory tests. The assay is also to be used as an aid in evaluating immune status of infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine, by quantitatively measuring IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2.
More details

Molecular Diagnostics Analyzer
ALINITY m

The ALINITY m is a fully integrated and automated molecular diagnostics analyzer that uses innovative technology to deliver the next level of flexibility and efficiency to the lab. With its Readiflex technology, 20 onboard assay capacity and broad assay menu, the allows consolidation of 60% of routine PCR testing on one instrument.
More details

SARS-CoV-2 Assay
Abbott RealTime SARS-CoV-2 Assay

The Abbott RealTime SARS-COV-2 Assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acids from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from patients who are suspected of COVID-19 by their healthcare provider. Engineered with dual target assay for RdRp and N-genes, it provides a fully automated solution to help laboratories address the urgent need for patient testing during the Coronavirus (COVID-19) pandemic.
More details

Sample Preparation System
m24sp

The m24sp is an instrument for laboratories with mid-throughput requirements that offers automated flexibility. An automated bench-top system with a small footprint, the m24sp features reliable extraction using mSample Preparation chemistry and variable extraction with ready-to-use and re-usable reagents plus flexible batch size.
More details

SARS-CoV-2 Antibody Test
AdviseDx SARS-CoV-2 IgM Assay

The AdviseDx SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin). The assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection and should not be used to diagnose acute SARS-CoV-2 infection.
More details

SARS-CoV-2 Antibody Test
SARS-CoV-2 IgG Assay

The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin). The assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection and should not be used to diagnose acute SARS-CoV-2 infection.
More details

SARS-CoV-2 Assay
Alinity m SARS-CoV-2 Assay

The Alinity m SARS-CoV-2 Assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs collected by a healthcare provider, from patients who are suspected of COVID-19 infection. The assay runs on the Alinity m system having a simple workflow with primary sample tube loading to provide operational efficiencies to curb the increasing testing volume with the existing lab staff.
More details

Point-Of-Care Testing

Molecular Diagnostics System
ID NOW

The ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases and uses isothermal nucleic acid amplification technology for providing molecular results in minutes. The intuitively designed instrument features a large visual touchscreen for displaying the results, eliminating transcription errors and the need for printing, while its small footprint saves bench space for use in any healthcare setting.
More details

COVID-19 Antigen Test
BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card rapid antigen test, which has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA), offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19. The BinaxNOW test can be displayed on Abbott’s new optional app - available at no charge - for iPhone and Android devices called NAVICA. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.
More details

COVID-19 Antigen Test
Panbio COVID-19 Ag Rapid Test Device

The Panbio COVID-19 Ag Rapid Test Device is intended for patients suspected of current COVID-19 infection and identifies potentially contagious patients in 15 minutes. Using patient-friendly nasal or nasopharyngeal sample collection types, the high performance rapid test enables immediate treatment or isolation measures to minimize transmission. The product is not available in all countries and available in select markets.
More details

COVID-19 Anitibody Test
Panbio COVID-19 IgG/IgM Rapid Test Device

The Panbio COVID-19 IgG/IgM Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood. The test provides preliminary test results within 10-20 minutes and is not intended to be used as a donor screening test for SARS-CoV-2. The product is not available in all countries and available in select markets.
More details

COVID-19 Test
ID NOW COVID-19

The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. The easy to use ID NOW platform is designed for near-patient, point-of-care use in a variety of healthcare settings.
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About Abbott Diagnostics

Abbott Diagnostics provides medical diagnostic instruments, tests, automation and informatics solutions, including clinical chemistry and immunoassay analyzers and hematology solutions. The company’s offerings are ideal for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics.

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Legionella Urinary Antigen Test
Binax Legionella Urinary Antigen EIA

The Binax Legionella Urinary Antigen EIA kit is an enzyme immunoassay (EIA) intended to qualitatively detect the presence of Legionella pneumophila serogroup 1 antigen in urine as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires’ disease. It provides accurate identification of Legionnaires’ disease caused by Legionella pneumophila serogroup 1 in a standard 96 well EIA format.
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Pneumonia Test
BinaxNOW S. pneumoniae Antigen Card

BinaxNOW S. pneumoniae Antigen Card is a rapid assay for the qualitative detection of S. pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended to aid, in conjunction with culture and other methods, in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.
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Strep A Test
BinaxNOW Strep A

The BinaxNOW Strep A test is a rapid immunochromatographic assay for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens. It utilizes a simple-to-use onboard extraction system to aid in the diagnosis of Group A pharyngitis.
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Hospital Infrastructure

POC Management Solutions
AegisPOC

The AegisPOC Point of Care Management Solutions is a web-based, open platform which connects point-of-care (POC) devices located in the hospital or community with the laboratory. It allows the laboratory to better manage and share data from POC devices on one flexible, scalable middleware.
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Surgery

Spinal Cord Stimulation System
Eterna SCS System

The Eterna Spinal Cord Stimulation (SCS) System is the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain. Eterna SCS utilizes Abbott's proprietary low-dose BurstDR stimulation, the only SCS waveform technology with the highest level of clinical evidence, proven to reduce pain 23% more than traditional waveform technology approaches. The U.S. FDA-approved neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems.
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Clinical Laboratory

Legionella Urinary Antigen Test
Binax Legionella Urinary Antigen EIA

The Binax Legionella Urinary Antigen EIA kit is an enzyme immunoassay (EIA) intended to qualitatively detect the presence of Legionella pneumophila serogroup 1 antigen in urine as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires’ disease. It provides accurate identification of Legionnaires’ disease caused by Legionella pneumophila serogroup 1 in a standard 96 well EIA format.
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Pneumonia Test
BinaxNOW S. pneumoniae Antigen Card

BinaxNOW S. pneumoniae Antigen Card is a rapid assay for the qualitative detection of S. pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended to aid, in conjunction with culture and other methods, in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.
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Strep A Test
BinaxNOW Strep A

The BinaxNOW Strep A test is a rapid immunochromatographic assay for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens. It utilizes a simple-to-use onboard extraction system to aid in the diagnosis of Group A pharyngitis.
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hCG Urine Test
Alere hCG Cassette (20 mIU/mL)

The Alere hCG Cassette (20 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including mouse monoclonal anti-hCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG.
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HbA1c Assay
Afinion HbA1c Assay

The Afinion HbA1c assay is a test for the quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used to monitor metabolic control in patients with diabetes. It provides immediate test results needed for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies.
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Lipid Panel Test
Afinion Lipid Panel

The Afinion Lipid Panel test is intended for the quantitative determination of Total Cholesterol, High-Density Lipoprotein (HDL) cholesterol, Low- Density Lipoprotein (LDL) cholesterol, Triglycerides (Trig), non-HDL and Chol/HDL ratio in whole blood, serum, and plasma. It runs on the fully automated Afinion Analyzer and is meant to be used in the diagnosis and treatment of lipid disorders.
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ACR Test Cartridge
Afinion ACR

The Afinion ACR (albumin, creatinine and albumin/creatinine ratio) detects microalbuminuria in human urine and is used for early identification of renal disease in patients with diabetes and/or hypertension. The Afinion ACR Test Cartridge contains all reagents necessary for the measurement of ACR ratio and gives reliable results conveniently available when and where needed.
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POC Single-Use IVD Test
i-STAT CHEM8+ Cartridge

The i-STAT CHEM8+ cartridge allows healthcare professionals to obtain chemistries, electrolytes, hematocrit and hemoglobin levels in approximately two minutes without leaving the patient's side. It can be used to rapidly assess the metabolic status of patients in a variety of clinical settings including critical care, surgery, radiology, acute and emergency care, and community-based settings.
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HIV-1 RT-PCR Assay
RealTime HIV-1

The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) in whole blood spotted on cards as dried blood spots (DBS) (i.e. obtained via venipuncture or capillary blood) or human plasma from HIV-1 infected individuals. Its unique assay design comprising partially double stranded probe, highly conserved target region and specific temperature profile ensures reliable detection of all groups and subtypes.
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Hepatitis C Test
RealTime HCV Genotype II

The RealTime HCV Genotype II assay determines the genotypes of hepatitis C virus in plasma and serum of HCV-infected individuals. It offers consolidated hepatitis testing of both HCV genotype and viral load on the fully automated Abbott m2000sp/rt platform.
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HBV Viral Load Assay
RealTime HBV

The Abbott RealTime HBV Viral Load Assay is intended for the quantitation of Hepatitis B virus in chronically infected HBV individuals. It delivers accurate quantitation of genotypes A, B, C, D, E, F, G, H and consists of three reagent kits.
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POC Test Reader
NycoCard READER II

The NycoCard READER II is a small battery powered instrument, designed to measure all NycoCard products. It consists of two units: the instrument box, which is the operational and calculating unit, and the Reader pen, which detects the signal. It gives reliable results conveniently available when and where needed and allows patient consultations to be carried out with confidence.
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Strep A Test
ID NOW Strep A 2

The CLIA waived ID NOW Strep A 2 test provides molecular results in six minutes or less on the ID NOW platform; allowing to confidently test, and with a positive result, treat, during the patient’s visit. Faster than other molecular methods and more accurate than conventional rapid tests, ID NOW Strep A 2 delivers results within an actionable time frame, enabling real-time clinical decisions which impact patient care.
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Legionella Urinary Antigen Test
BinaxNow Legionella Urinary Antigen Card

BinaxNow Legionella Urinary Antigen Card is a rapid assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine samples from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionnaires’ disease caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.
More details

Malaria Test
BinaxNOW Malaria

The BinaxNOW Malaria test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a pan-malarial antigen common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.).
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TBI Blood Test
i-STAT TBI Plasma Test

The i-STAT TBI Plasma Test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in plasma and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity Instrument. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.
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Lipid Profile Analyzer
Cholestech LDX

The CLIA-waived Cholestech LDX Analyzer offers efficient and economical point of care testing for cholesterol and related lipids, and blood glucose to serve as diagnostic tools that provide information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.
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Hepatitis B Antigen Test
Determine HBsAg 2

Determine HBsAg 2 is the world's most sensitive rapid diagnostic test for detection of hepatitis B surface antigen for use with serum, plasma or whole blood. With an analytical sensitivity of just 0.1 IU/mL, the highly sensitive, easy to use rapid lateral flow test enables quick, accurate identification of HBsAg positive patients, increasing HBV case finding and facilitating fast and appropriate linkage to care in any healthcare setting.
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SARS-CoV-2 IgG Immunoassay
SARS-CoV-2 IgG II Quant

The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Alinity and ARCHITECT i Systems. The assay is to be used as an aid in the diagnosis of SARS-CoV-2 infection in conjunction with clinical presentation and other laboratory tests. The assay is also to be used as an aid in evaluating immune status of infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine, by quantitatively measuring IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2.
More details

COVID-19 Test
ID NOW COVID-19

The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. The easy to use ID NOW platform is designed for near-patient, point-of-care use in a variety of healthcare settings.
More details

SARS-CoV-2 Antibody Test
Panbio SARS-CoV-2 IgG ELISA

The Panbio SARS-CoV-2 IgG ELISA is an antibody test that helps identify individuals with immune response to SARS-CoV-2 and enables greater access for broad population surveillance. The test is compatible with manual ELISA, and is adaptable to semi-automated and fully-automated equipment, enabling easy deployment within a lab's existing infrastructure. The product is not available in all countries and available in select markets.
More details

COVID-19 Anitibody Test
Panbio COVID-19 IgG/IgM Rapid Test Device

The Panbio COVID-19 IgG/IgM Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood. The test provides preliminary test results within 10-20 minutes and is not intended to be used as a donor screening test for SARS-CoV-2. The product is not available in all countries and available in select markets.
More details

COVID-19 Antigen Test
Panbio COVID-19 Ag Rapid Test Device

The Panbio COVID-19 Ag Rapid Test Device is intended for patients suspected of current COVID-19 infection and identifies potentially contagious patients in 15 minutes. Using patient-friendly nasal or nasopharyngeal sample collection types, the high performance rapid test enables immediate treatment or isolation measures to minimize transmission. The product is not available in all countries and available in select markets.
More details

SARS-CoV-2 Antibody Test
SARS-CoV-2 IgG Assay

The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin). The assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection and should not be used to diagnose acute SARS-CoV-2 infection.
More details

SARS-CoV-2 Antibody Test
AdviseDx SARS-CoV-2 IgM Assay

The AdviseDx SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin). The assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection and should not be used to diagnose acute SARS-CoV-2 infection.
More details

COVID-19 Antigen Test
BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card rapid antigen test, which has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA), offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19. The BinaxNOW test can be displayed on Abbott’s new optional app - available at no charge - for iPhone and Android devices called NAVICA. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.
More details

Molecular Diagnostics Analyzer
ALINITY m

The ALINITY m is a fully integrated and automated molecular diagnostics analyzer that uses innovative technology to deliver the next level of flexibility and efficiency to the lab. With its Readiflex technology, 20 onboard assay capacity and broad assay menu, the allows consolidation of 60% of routine PCR testing on one instrument.
More details

Sample Preparation System
m24sp

The m24sp is an instrument for laboratories with mid-throughput requirements that offers automated flexibility. An automated bench-top system with a small footprint, the m24sp features reliable extraction using mSample Preparation chemistry and variable extraction with ready-to-use and re-usable reagents plus flexible batch size.
More details

SARS-CoV-2 Assay
Abbott RealTime SARS-CoV-2 Assay

The Abbott RealTime SARS-COV-2 Assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acids from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from patients who are suspected of COVID-19 by their healthcare provider. Engineered with dual target assay for RdRp and N-genes, it provides a fully automated solution to help laboratories address the urgent need for patient testing during the Coronavirus (COVID-19) pandemic.
More details

SARS-CoV-2 Assay
Alinity m SARS-CoV-2 Assay

The Alinity m SARS-CoV-2 Assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs collected by a healthcare provider, from patients who are suspected of COVID-19 infection. The assay runs on the Alinity m system having a simple workflow with primary sample tube loading to provide operational efficiencies to curb the increasing testing volume with the existing lab staff.
More details

Chemistry & Immunoassay Analyzer
ARCHITECT ci8200

The ARCHITECT ci8200 combines the ARCHITECT c8000 and the ARCHITECT i2000SR to provide clinical chemistry and immunoassay testing in a single integrated system. It offers a maximum throughput of up to 1,400 tests per hour, including 1,200 clinical chemistry and 200 immunoassay tests.
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Bladder Cancer Kit
UroVysion Kit

The UroVysion Bladder Cancer Kit is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. It delivers definitive results in atypical cytology cases with equivocal or negative cystoscopy and is the only urine-based molecular test approved by the FDA to aid bladder cancer surveillance and assist with diagnosis.
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Preanalytical System
ACCELERATOR p540

The ACCELERATOR p540 automatic preanalytical system reduces the opportunities for errors and boosts lab efficiency by automating preanalytical activities. It automates primary tube accessioning, decapping, aliquoting, sorting and centrifugation to improve workflow efficiency for laboratories limited by space or budget.
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Molecular Diagnostics System
ID NOW

The ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases and uses isothermal nucleic acid amplification technology for providing molecular results in minutes. The intuitively designed instrument features a large visual touchscreen for displaying the results, eliminating transcription errors and the need for printing, while its small footprint saves bench space for use in any healthcare setting.
More details

Multi-Assay Analyzer
Afinion 2 Analyzer

The Afinion 2 Analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care, eliminating the need for sending patients to the lab or spending time tracking down their results. The analyzer makes it fast and easy to test quantitative determinations of HbA1c, Lipid Panel, ACR, and CRP on-the-spot, regardless of the sample type, which may be whole blood, plasma or urine.
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Real-time PCR Instrument
m2000 RealTime System

The m2000 RealTime System is a polymerase chain reaction (PCR) platform that allows laboratories to simplify the complex process of molecular diagnostics while minimizing contamination. It features a broad menu of IVD assays and allows for the consolidation of PCR testing on a single, reliable, high performance platform.
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Immunoassay Analyzer
ARCHITECT i1000SR

The ARCHITECT i1000SR immunoassay analyzer has built-in flexible protocols that enhance laboratory workflow and allow reporting of results with confidence. It has a maximum throughput of up to 100 tests per hour and requires a sample volume of 10-150 μL (average 62 µL) of serum, plasma, whole blood or urine.
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Services & Informatics Solution
AlinIQ

The AlinIQ is a first-of-its-kind professional services and informatics solution that will enable labs to deliver greater overall productivity with their existing resources. It includes four key offerings combining professional service experts with processes and tools that help uncover intelligent insights from laboratory data.
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Immunoassay Analyzer
ARCHITECT i2000SR

The ARCHITECT i2000SR immunoassay analyzer features a load-up capacity of 135 samples with 35 priority and 100 routine areas, and has 25 refrigerated reagent positions. It offers a maximum throughput of up to 200 tests per hour and can be integrated with the ARCHITECT c8000 or c16000 clinical chemistry analyzers to consolidate clinical chemistry and immunoassay testing into one module.
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Blood/Plasma Screening System
Alinity s

The Alinity s system for blood and plasma screening has the capacity to run up to 600 tests per hour in a compact footprint and provides the ability to load samples and walk away for a minimum of three hours while the samples are analyzed. It offers continuous access to samples and supplies which means that the samples are reloaded without pausing or stopping the instrument, thus avoiding costly downtime.
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Hematology Analyzer
CELL-DYN Emerald

The CELL-DYN Emerald hematology analyzer’s small size, simple touch screen software and reliability offer an easy-to-use, truly compact table/bench top instrument for easy performance in the laboratory. It provides accurate patient results in less than 65 seconds using proven methods and technology, including electronic impedance, absorption spectrophotometry, electronic valves, and cyanide-free lyse reagent.
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Blood Analyzer
i-STAT Wireless

The i-STAT Wireless is an easy-to-use blood analyzer that operates with the advanced technology of single-use i-STAT test cartridges to make patient-side testing fast, easy and accurate. It allows the user to perform diagnostic tests and upload results to the EMR automatically from many patient care areas, and is compatible with 802.11b/802.11g wireless networks.
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Rapid Test
ABBOTT Determine

The ABBOTT Determine rapid tests allow the screening and support in the detection of HIV, tuberculosis, hepatitis B, and syphilis in just 25 minutes. This point-of-care platform requires minimal training, can be easily stored and transported and is ideal for any setting.
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Chemistry/Immunoassay System
ARCHITECT ci8200

The ARCHITECT ci8200 combines the ARCHITECT c8000 and the ARCHITECT i2000SR to provide clinical chemistry and immunoassay testing in a single integrated system. It offers a maximum throughput of up to 1,400 tests per hour, including 1,200 clinical chemistry and 200 immunoassay tests, allowing laboratories to handle complex workloads.
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Chemistry/Immunoassay System
ARCHITECT ci4100

The ARCHITECT ci4100 combines the ARCHITECT c4000 and ARCHITECT i1000SR instruments to provide clinical chemistry and immunoassay testing in a single integrated system. It offers a maximum throughput of up to 900 tests per hour, including 800 clinical chemistry and 100 immunoassay tests, allowing lower volume laboratories to enjoy enhanced efficiency and productivity.
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Immunoassay Analyzer
ARCHITECT i4000SR

The ARCHITECT i4000SR is a multi-module immunoassay analyzer system consisting of two ARCHITECT i2000SR systems that provide enhanced productivity for labs with high-volume immunoassay demands. Featuring a load-up capacity of 285 samples with 35 priority and 250 routine areas, it has 50 refrigerated reagent positions to deliver high throughput for high-quality STAT results when you need them.
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Hematology Analyzer
CELL-DYN Emerald 22 AL

The CELL-DYN Emerald 22 AL is a full performance, automated optical 5-part differential hematology analyzer that conserves valuable laboratory space with a small footprint and only two reagents, plus onboard cleaner. It optimizes hematology workflow with 50 tube load-up capacity and reducing hands-on time with touch-free scheduled daily maintenance, start-up and shutdown.
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Clinical Chemistry Analyzer
ARCHITECT c4000

The ARCHITECT c4000 clinical chemistry analyzer offers a maximum throughput of up to 800 tests per hour, demonstrating high-quality testing results and rapid STAT turnaround time. Featuring a load-up capacity of 100 samples with 35 priority positions, it allows for up to 90 refrigerated reagent positions on board, plus Integrated Chip Technology (Na+, K+ and Cl-).
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Immunoassay Analyzer
ARCHITECT i4000SR

The ARCHITECT i4000SR immunoassay analyzer is a multi-module system consisting of two ARCHITECT i2000SR systems and offers a maximum throughput of up to 400 tests per hour. Featuring a load-up capacity of 285 samples with 35 priority and 250 routine areas, it provides enhanced productivity for labs with high-volume immunoassay demands.
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Clinical Chemistry Analyzer
ARCHITECT C8000

The ARCHITECT C8000 clinical chemistry analyzer offers a maximum throughput of up to 1,200 tests per hour and features a load-up capacity of 215 samples with 35 priority positions. It has up to 121 refrigerated reagent positions, plus Integrated Chip Technology (Na+, K+ and Cl-), and a consistent STAT turnaround time.
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Hematology Analyzer
Alinity h-series

The Alinity h-series solution for hematology testing integrates the Alinity hq with the Alinity hs slide maker and stainer module and has a throughput of 133 complete blood counts (CBCs) per m2. The integrated system offers an intuitive user experience with iconography, color coding and reporting features shared by all Alinity platforms.
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Hematology Analyzer
CELL-DYN Ruby

The CELL-DYN Ruby hematology analyzer requires only three reagents needed to perform a complete blood count (CBC) with 5-part WBC differential analysis, and reduces the need for microscopic blood smear reviews and repeat testing. It improves efficiency by providing rules-based annotations to standardize laboratory processes, thereby providing consistency in result handling among all laboratory personnel.
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Lab Automation System
ACCELERATOR a3600

The ACCELERATOR a3600 is a total laboratory automation system that combines informatics and lean principles to maximize efficiency by providing consistent, predictable sample management and help improve patient care by minimizing opportunities for error. It offers open third party analyzer connectivity, and its modular design allows for creating a customized design to fit any laboratory.
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Immunoassay Analyzer
PRISMnEXT

The PRISMnEXT is a fully automated immunoassay analyzer designed to perform Chemiluminescent Immunoassay (ChLIA) technology and provide automated processes that deliver high throughput, walk-away testing protocols. It performs batch/continuous access and STAT processing of specimens containing both large and small molecular weight analytes. It enhances process automation and cGMP compliance and offers a comprehensive menu of blood screening assays.
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Chem Immunoassay System
Alinity ci-series

The Alinity ci-series integrated clinical chemistry and immunoassay system consists of compact, scalable systems to maximize throughput and efficiency, making today's high-performing laboratories run at their best, today and into the future. With an emphasis on user-driven design, the Alinity ci-series offers an intuitive and universal experience with other Alinity systems, so your staff can easily transition from one system to the next.
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Immunoassay System
Alinity i

The Alinity I is a compact, immunoassay system that utilizes CHEMIFLEX technology and maximizes throughput. Designed with a universal, intuitive interface, it can run more tests in less space, generate test results faster and minimize human errors.
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Clinical Chemistry Analyzer
Alinity c

The Alinity c is a compact, clinical chemistry system that maximizes throughput of photometric and potentiometric assays. Designed with a universal, intuitive interface, it can run more tests in less space, generate test results faster and minimize human errors.
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Hematology System
CELL-DYN Emerald 22

The CELL-DYN Emerald 22 is a full performance hematology analyzer for smaller clinical laboratories seeking better productivity with small spaces. Specifically designed with space in mind, it is one of the smallest 5-part differential analyzers on the market and includes a numeric keypad entry, reagent tray, and integrated color touchscreen monitor.
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Hematology Analyzer
Alinity hq

The Alinity hq is a next-generation hematology analyzer designed to streamline workflow and transform operational performance to help laboratories and hospital systems achieve measurably better healthcare performance. It maximizes throughput and efficiency, and has been designed from the ground-up with user-focused design elements that can address the need for managing a changing workload with existing resources. Alinity hq not available in all countries, including the USA.
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Portable Blood Analyzer
i-STAT handheld

The i-STAT handheld is a portable blood analyzer that operates with single-use i-STAT test cartridges covering a large menu of commonly used tests in one platform. It provides lab-quality results in minutes, allowing health care professionals to quickly respond to any need and condition at the patient's side.
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Blood Analyzer
i-STAT Alinity

The i-STAT Alinity System is a handheld blood testing platform that can perform and analyze the largest menu of blood tests on a single device, ranging from blood chemistries to cardiac markers. It uses only two to three drops of a person's blood and delivers results in two to 10 minutes, making it ideal for healthcare professionals who need information to make fast and accurate medical decisions without ever leaving their patient's side.
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Handheld POC Pregnancy Test
i-STAT Total β-hCG

The i-STAT Total β-hCG is a handheld point of care pregnancy test that uses whole blood to provide lab-quality, quantitative and qualitative results, which can be documented automatically through wireless transmission with the i-STAT 1 Wireless System. It expedites physicians’ assessment and diagnosis of patients by providing results in 10 minutes and reduces the risk of false results, potentially allowing for more confident clinical decision.
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Hematology System
CELL-DYN Sapphire

The CELL-DYN Sapphire hematology system offers fully automated, random access monoclonal antibody analysis with a reportable CD61 immunoplatelet count provided in about 5 minutes, and CD3/4 and CD3/8 immuno T-cell count in about 7 minutes. It features MultiAngle Polarized Scatter Separation (MAPSS) technology plus 3-color fluorescence and is suitable for high-volume hematology labs.
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Clinical Chemistry Analyzer
ARCHITECT c16000

The ARCHITECT c16000 clinical chemistry analyzer features a load-up capacity of 215 samples with 35 priority positions and 65 refrigerated reagent positions. It offers a maximum throughput of up to 1,800 tests per hour, and is integrated with the ARCHITECT i2000SR immunoassay analyzer for allowing laboratories to handle clinical chemistry and immunoassay testing on one platform.
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Immunoassay System
ARCHITECT ci16200

The ARCHITECT ci16200 offers a maximum throughput of up to 2,000 tests per hour, including 1,800 clinical chemistry tests and 200 immunoassays. Featuring a load-up capacity of 365 samples with 35 priority positions, and 90 refrigerated reagent positions, it provides clinical chemistry and immunoassay testing on a single platform for larger laboratories.
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Immunoassay System
ARCHITECT i4000SR

The ARCHITECT i4000SR is a multi-module system consisting of two ARCHITECT i2000SR integrated systems with a load-up capacity of 285 samples with 35 priority and 250 routine areas, and 50 refrigerated reagent positions. It delivers a maximum throughput of up to 400 tests per hour, making it suitable for labs with high-volume immunoassay requirements.
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Point-Of-Care Testing

POC Single-Use IVD Test
i-STAT CHEM8+ Cartridge

The i-STAT CHEM8+ cartridge allows healthcare professionals to obtain chemistries, electrolytes, hematocrit and hemoglobin levels in approximately two minutes without leaving the patient's side. It can be used to rapidly assess the metabolic status of patients in a variety of clinical settings including critical care, surgery, radiology, acute and emergency care, and community-based settings.
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POC Test Reader
NycoCard READER II

The NycoCard READER II is a small battery powered instrument, designed to measure all NycoCard products. It consists of two units: the instrument box, which is the operational and calculating unit, and the Reader pen, which detects the signal. It gives reliable results conveniently available when and where needed and allows patient consultations to be carried out with confidence.
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Strep A Test
ID NOW Strep A 2

The CLIA waived ID NOW Strep A 2 test provides molecular results in six minutes or less on the ID NOW platform; allowing to confidently test, and with a positive result, treat, during the patient’s visit. Faster than other molecular methods and more accurate than conventional rapid tests, ID NOW Strep A 2 delivers results within an actionable time frame, enabling real-time clinical decisions which impact patient care.
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Malaria Test
BinaxNOW Malaria

The BinaxNOW Malaria test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a pan-malarial antigen common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.).
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TBI Blood Test
i-STAT TBI Plasma Test

The i-STAT TBI Plasma Test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in plasma and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity Instrument. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.
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Lipid Profile Analyzer
Cholestech LDX

The CLIA-waived Cholestech LDX Analyzer offers efficient and economical point of care testing for cholesterol and related lipids, and blood glucose to serve as diagnostic tools that provide information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.
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COVID-19 Test
ID NOW COVID-19

The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. The easy to use ID NOW platform is designed for near-patient, point-of-care use in a variety of healthcare settings.
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COVID-19 Anitibody Test
Panbio COVID-19 IgG/IgM Rapid Test Device

The Panbio COVID-19 IgG/IgM Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood. The test provides preliminary test results within 10-20 minutes and is not intended to be used as a donor screening test for SARS-CoV-2. The product is not available in all countries and available in select markets.
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COVID-19 Antigen Test
Panbio COVID-19 Ag Rapid Test Device

The Panbio COVID-19 Ag Rapid Test Device is intended for patients suspected of current COVID-19 infection and identifies potentially contagious patients in 15 minutes. Using patient-friendly nasal or nasopharyngeal sample collection types, the high performance rapid test enables immediate treatment or isolation measures to minimize transmission. The product is not available in all countries and available in select markets.
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COVID-19 Antigen Test
BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card rapid antigen test, which has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA), offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19. The BinaxNOW test can be displayed on Abbott’s new optional app - available at no charge - for iPhone and Android devices called NAVICA. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.
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Molecular Diagnostics System
ID NOW

The ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases and uses isothermal nucleic acid amplification technology for providing molecular results in minutes. The intuitively designed instrument features a large visual touchscreen for displaying the results, eliminating transcription errors and the need for printing, while its small footprint saves bench space for use in any healthcare setting.
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Multi-Assay Analyzer
Afinion 2 Analyzer

The Afinion 2 Analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care, eliminating the need for sending patients to the lab or spending time tracking down their results. The analyzer makes it fast and easy to test quantitative determinations of HbA1c, Lipid Panel, ACR, and CRP on-the-spot, regardless of the sample type, which may be whole blood, plasma or urine.
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Blood Analyzer
i-STAT Wireless

The i-STAT Wireless is an easy-to-use blood analyzer that operates with the advanced technology of single-use i-STAT test cartridges to make patient-side testing fast, easy and accurate. It allows the user to perform diagnostic tests and upload results to the EMR automatically from many patient care areas, and is compatible with 802.11b/802.11g wireless networks.
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Rapid Test
ABBOTT Determine

The ABBOTT Determine rapid tests allow the screening and support in the detection of HIV, tuberculosis, hepatitis B, and syphilis in just 25 minutes. This point-of-care platform requires minimal training, can be easily stored and transported and is ideal for any setting.
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POC Management Solutions
AegisPOC

The AegisPOC Point of Care Management Solutions is a web-based, open platform which connects point-of-care (POC) devices located in the hospital or community with the laboratory. It allows the laboratory to better manage and share data from POC devices on one flexible, scalable middleware.
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Portable Blood Analyzer
i-STAT handheld

The i-STAT handheld is a portable blood analyzer that operates with single-use i-STAT test cartridges covering a large menu of commonly used tests in one platform. It provides lab-quality results in minutes, allowing health care professionals to quickly respond to any need and condition at the patient's side.
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Blood Analyzer
i-STAT Alinity

The i-STAT Alinity System is a handheld blood testing platform that can perform and analyze the largest menu of blood tests on a single device, ranging from blood chemistries to cardiac markers. It uses only two to three drops of a person's blood and delivers results in two to 10 minutes, making it ideal for healthcare professionals who need information to make fast and accurate medical decisions without ever leaving their patient's side.
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Handheld POC Pregnancy Test
i-STAT Total β-hCG

The i-STAT Total β-hCG is a handheld point of care pregnancy test that uses whole blood to provide lab-quality, quantitative and qualitative results, which can be documented automatically through wireless transmission with the i-STAT 1 Wireless System. It expedites physicians’ assessment and diagnosis of patients by providing results in 10 minutes and reduces the risk of false results, potentially allowing for more confident clinical decision.
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