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Roche Diagnostics

Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests
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Covid-19 Roche Diagnostics

Clinical Laboratory

SARS-CoV-2 Variant Test
cobas SARS-CoV-2 Variant Set 1

The cobas SARS-CoV-2 Variant Set 1 for use on the cobas 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations N501Y, deletion HV-69/70 and E484K in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management. The assay is intended for research use only and is not for use in diagnostic procedures.
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SARS-CoV-2 Rapid Antibody Test
SARS-CoV-2 Rapid Antibody Test

The SARS-CoV-2 Rapid Antibody Test is a reliable, rapid chromatographic immunoassay intended for qualitative detection of antibodies (IgM and IgG) to SARS-CoV-2 in human serum, plasma or whole blood. It is intended for the use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. The rapid lateral flow test is intended for professional use in laboratory and near patient-testing environments and qualitatively detects IgM and IgG specific to SARS-CoV-2 in serum, plasma, and whole blood.
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SARS-CoV-2 Rapid Antigen Test Nasal
SARS-CoV-2 Rapid Antigen Test Nasal

The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS‑CoV‑2 nucleocapsid antigen present in human nasal samples. The test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2. The product is intended for professional use in laboratory and Point of Care environments, or self-collection under the supervision of a healthcare worker.
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SARS-CoV-2 Antigen Assay
Elecsys SARS-CoV-2 Antigen

The Elecsys SARS-CoV-2 Antigen assay uses monoclonal antibodies directed against the SARS-CoV-2 N protein in a double-antibody sandwich assay format for the qualitative detection of SARS-CoV-2 in upper respiratory tract specimens.
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SARS-CoV-2 & Flu A/B Nucleic Acid Test
cobas SARS-CoV-2 & Influenza A/B Assay

The cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, influenza A and influenza B in 20 minutes from a single nasal sample and in just one test. It is intended for use in the detection and differentiation of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in upper respiratory specimens during infection.
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SARS-CoV-2 Test
SARS-CoV-2 Rapid Antigen Test

The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19 and is strictly intended for professional use in laboratory and Point of Care environment.
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SARS-CoV-2 Test
Elecsys Anti-SARS-CoV-2 S

The Elecsys Anti-SARS-CoV-2 S is an immunoassay for the in vitro quantitative determination of antibodies (including IgG) to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma. The assay uses a recombinant protein representing the RBD of the S antigen in a double-antigen sandwich assay format, which favors detection of high affinity antibodies against SARS‑CoV‑2. The test is intended as an aid to assess the adaptive humoral immune response to the SARS‑CoV‑2 S protein.
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SARS-CoV-2 & Influenza Test
cobas SARS-CoV-2 & Influenza A/B Test

The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control. It is the first commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample.
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SARS-CoV-2 Test
cobas SARS-CoV-2 Test

The cobas SARS-CoV-2 Test is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria and is intended for use on the automated, high throughput cobas 6800/8800 Systems. The single-well dual target assay includes both specific detection of SARS-CoV-2 (COVID-19 Coronavirus) and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2.
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Anti-SARS-CoV-2 Test
Elecsys Anti-SARS-CoV-2

The Elecsys Anti-SARS-CoV-2 is an immunoassay intended for qualitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (K2‑EDTA, K3‑EDTA, Li‑heparin) to be used as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. The electrochemiluminescence immunoassay (ECLIA) uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2 and is intended for use on cobas e immunoassay analyzers.
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IL-6 Immunoassay
Elecsys IL-6 immunoassay

The Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL 6 (interleukin 6) in human serum or plasma and is used to help clinicians quickly identify COVID-19 patients with severe inflammatory response who need mechanical ventilation. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay (ECLIA) and is intended for use on cobas e immunoassay analyzers.
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News of Roche Diagnostics

Roche to Acquire Genmark Diagnostics to Access Novel Technology to Test for Pathogens with One Patient Sample

16 Mar 2021
Roche to Acquire Genmark Diagnostics to Access Novel Technology to Test for Pathogens with One Patient Sample
Roche (Basel, Switzerland) and GenMark Diagnostics, Inc. (Carlsbad, CA, USA) have entered into a definitive merger agreement for Roche to fully acquire GenMark which provides molecular diagnostic tests that are designed to detect multiple pathogens from a single patient sample.
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Roche Renews Partnership with Sysmex to Deliver Hematology Testing Solutions

26 Jan 2021
Roche Renews Partnership with Sysmex to Deliver Hematology Testing Solutions
Under the new framework of a Global Business Partnership Agreement (GBP) signed between Roche (Basel, Switzerland) and Sysmex Corporation (Kobe, Japan), both the companies have renewed their commitment to their long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex hematology products, including instruments and reagents.
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Roche Launches Digital Pathology Image Analysis Algorithms for Precision Patient Diagnosis in Breast Cancer

13 Jan 2021
Roche Launches Digital Pathology Image Analysis Algorithms for Precision Patient Diagnosis in Breast Cancer
Roche (Basel, Switzerland) has announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient.
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Roche lanza Roche Healthcare Consulting

24 Oct 2018
Roche lanza Roche Healthcare Consulting
Roche (Basilea, Suiza) ha lanzado Roche Healthcare Consulting, un servicio de consultoría especializado que tiene como objetivo ayudar a los líderes en los laboratorios, hospitales y otros grupos de atención médica a optimizar su desempeño operativo, clínico y financiero.

 
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Roche Launches Roche Healthcare Consulting

18 Oct 2018
Roche Launches Roche Healthcare Consulting
Roche (Basel, Switzerland) has launched Roche Healthcare Consulting, a specialized consulting service that aims to help leaders in laboratories, hospitals and other healthcare groups optimize their operational, clinical and financial performance.
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About Roche Diagnostics

Number of Employees: 1000+
Year of Establishment: 1896
Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests

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Cardiovascular Disease POC Analyzer
cobas h 232 POC System

The cobas h 232 POC system is a portable point-of-care system that supports optimized treatment of patients with symptoms of chest pain and dyspnoea. It enables confident on-the-spot diagnosis and assessment of the patient’s condition based on objective results, comparable with Roche laboratory methods that can be shared wirelessly for immediate feedback and response. The cobas h 232 POC system allows rapid and easy determination of Troponin T, NT-proBNP, D-Dimer and CK-MB in different settings, like ambulances, general practitioner offices and emergency rooms.
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Troponin T Gen 5 STAT (hsTnT) Test
Elecsys Troponin T Gen 5 STAT (hsTnT)

Elecsys TnT Gen 5 STAT is FDA cleared to aid in the diagnosis of myocardial infarction (MI). TnT Gen 5 enables clinicians to more quickly diagnose patients with suspected MIs, delivering industry leading turnaround time results in only nine minutes. With the help of Roche’s high-sensitive Elecsys Troponin T Gen 5 STAT, emergency department scan reduce uncertainty in MI diagnosis to enable rapid treatment - contributing to better cost management.
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Point-Of-Care Anticoagulation Monitor
CoaguChek XS Plus System

The CoaguChek XS Plus system is a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. It has CLIA-waived status which means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the CLIA of 1988.
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Clinical Laboratory

Cardiovascular Disease POC Analyzer
cobas h 232 POC System

The cobas h 232 POC system is a portable point-of-care system that supports optimized treatment of patients with symptoms of chest pain and dyspnoea. It enables confident on-the-spot diagnosis and assessment of the patient’s condition based on objective results, comparable with Roche laboratory methods that can be shared wirelessly for immediate feedback and response. The cobas h 232 POC system allows rapid and easy determination of Troponin T, NT-proBNP, D-Dimer and CK-MB in different settings, like ambulances, general practitioner offices and emergency rooms.
More details

Troponin T Gen 5 STAT (hsTnT) Test
Elecsys Troponin T Gen 5 STAT (hsTnT)

Elecsys TnT Gen 5 STAT is FDA cleared to aid in the diagnosis of myocardial infarction (MI). TnT Gen 5 enables clinicians to more quickly diagnose patients with suspected MIs, delivering industry leading turnaround time results in only nine minutes. With the help of Roche’s high-sensitive Elecsys Troponin T Gen 5 STAT, emergency department scan reduce uncertainty in MI diagnosis to enable rapid treatment - contributing to better cost management.
More details

Point-Of-Care Anticoagulation Monitor
CoaguChek XS Plus System

The CoaguChek XS Plus system is a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. It has CLIA-waived status which means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the CLIA of 1988.
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Integrated Chemistry and Immunoassay Solution
cobas pure

cobas pure integrated solutions brings together three diagnostic technologies on a single platform to optimize space and resources in small to medium laboratory settings. With a footprint of just two square meters, this new analyzer can perform up to 870 tests per hour while providing small to medium sized labs with access to the full clinical chemistry and immunochemistry assay menu from Roche, including over 230 diagnostic tests across a wide-range of disease areas such as infectious diseases, oncology and cardiology.
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Integrated Chemistry and Immunoassay Solution
cobas pro

cobas pro integrated solutions is a scalable and modular solution designed to achieve mid-to-high volume clinical chemistry and immunochemistry testing needs. cobas pro integrated solutions can deliver up to 4,400 tests per hour and labs can benefit from eight new configurations. By consolidating a greater number of samples on a single platform and offering the industry’s broadest clinical chemistry and immunochemistry assay menu of over 230 diagnostic tests, the analyzer helps to simplify sample processing and laboratory workflows.
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SARS-CoV-2 & Flu A/B Nucleic Acid Test
cobas SARS-CoV-2 & Influenza A/B Assay

The cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, influenza A and influenza B in 20 minutes from a single nasal sample and in just one test. It is intended for use in the detection and differentiation of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in upper respiratory specimens during infection.
More details

SARS-CoV-2 Antigen Assay
Elecsys SARS-CoV-2 Antigen

The Elecsys SARS-CoV-2 Antigen assay uses monoclonal antibodies directed against the SARS-CoV-2 N protein in a double-antibody sandwich assay format for the qualitative detection of SARS-CoV-2 in upper respiratory tract specimens.
More details

SARS-CoV-2 Rapid Antigen Test Nasal
SARS-CoV-2 Rapid Antigen Test Nasal

The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS‑CoV‑2 nucleocapsid antigen present in human nasal samples. The test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2. The product is intended for professional use in laboratory and Point of Care environments, or self-collection under the supervision of a healthcare worker.
More details

SARS-CoV-2 Rapid Antibody Test
SARS-CoV-2 Rapid Antibody Test

The SARS-CoV-2 Rapid Antibody Test is a reliable, rapid chromatographic immunoassay intended for qualitative detection of antibodies (IgM and IgG) to SARS-CoV-2 in human serum, plasma or whole blood. It is intended for the use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. The rapid lateral flow test is intended for professional use in laboratory and near patient-testing environments and qualitatively detects IgM and IgG specific to SARS-CoV-2 in serum, plasma, and whole blood.
More details

SARS-CoV-2 Variant Test
cobas SARS-CoV-2 Variant Set 1

The cobas SARS-CoV-2 Variant Set 1 for use on the cobas 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations N501Y, deletion HV-69/70 and E484K in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management. The assay is intended for research use only and is not for use in diagnostic procedures.
More details

SARS-CoV-2 & Influenza Test
cobas SARS-CoV-2 & Influenza A/B Test

The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control. It is the first commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample.
More details

SARS-CoV-2 Test
Elecsys Anti-SARS-CoV-2 S

The Elecsys Anti-SARS-CoV-2 S is an immunoassay for the in vitro quantitative determination of antibodies (including IgG) to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma. The assay uses a recombinant protein representing the RBD of the S antigen in a double-antigen sandwich assay format, which favors detection of high affinity antibodies against SARS‑CoV‑2. The test is intended as an aid to assess the adaptive humoral immune response to the SARS‑CoV‑2 S protein.
More details

SARS-CoV-2 Test
SARS-CoV-2 Rapid Antigen Test

The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19 and is strictly intended for professional use in laboratory and Point of Care environment.
More details

IL-6 Immunoassay
Elecsys IL-6 immunoassay

The Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL 6 (interleukin 6) in human serum or plasma and is used to help clinicians quickly identify COVID-19 patients with severe inflammatory response who need mechanical ventilation. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay (ECLIA) and is intended for use on cobas e immunoassay analyzers.
More details

Anti-SARS-CoV-2 Test
Elecsys Anti-SARS-CoV-2

The Elecsys Anti-SARS-CoV-2 is an immunoassay intended for qualitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (K2‑EDTA, K3‑EDTA, Li‑heparin) to be used as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. The electrochemiluminescence immunoassay (ECLIA) uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2 and is intended for use on cobas e immunoassay analyzers.
More details

SARS-CoV-2 Test
cobas SARS-CoV-2 Test

The cobas SARS-CoV-2 Test is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria and is intended for use on the automated, high throughput cobas 6800/8800 Systems. The single-well dual target assay includes both specific detection of SARS-CoV-2 (COVID-19 Coronavirus) and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2.
More details

POC IT Solution
cobas infinity POC solution

The cobas infinity POC solution is an integrated web-based application with open connectivity that helps manage point of care testing from a single location using a desktop, tablet or mobile (iOS and Android) devices. The open software solution integrates with both Roche and non-Roche devices and with hospital and laboratory information systems, including HIS, LIS, HR, LMS and EMR systems.
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Pre-analytical Systems
cobas p 512/612

The cobas p 512/612 pre-analytical systems are standalone automation solutions validated for cross-contamination compliance, allowing them to be used for automating and simplifying processes in clinical laboratories and blood banks. Both systems perform a comprehensive inspection of samples at an early stage, optimizing the lab workflow and enabling the best use of time and resources, including tube type identification, liquid level detection, spin status detection and sample quality check.
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Automated Workflow Series
cobas 8100

The cobas 8100 automated workflow series delivers automation without compromise with its workflow your way concept enabling the user to choose workflows using primary, aliquot and mixed sample workflows. Its multi-level, bi-directional 3D intelligent sample transport design ensures efficient sample routing for multiple disciplines and predictable turnaround times during peak testing hours.
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Clinical Chemistry Analyzer
cobas c 311

The cobas c 311 analyzer is a standalone system that offers consolidated testing from a broad menu of clinical chemistry applications with the capacity for ion-selective electrode (ISE) determination of sodium, potassium, and chloride in serum, plasma, and urine. In addition, the measurement of HbA1c levels in whole blood can also be performed, making it a truly flexible clinical chemistry analyzer.
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Critical Care Analyzer
cobas b 123

The cobas b 123 is a mobile, cartridge-based, critical care analyzer designed for POC testing with flexible configurations and a throughput of up to 30 samples per hour. It requires no preventative maintenance, reducing analyzer downtime, and can be customized to the clinical needs of the ICU, ER, NICU, OR, dialysis units or the laboratory.
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Urine Analyzer
Urisys 1100

The Urisys 1100 urine analyzer is a semi-automated hand held urine testing analyzer for a workload of up to 50 urine samples per day. It is designed to improve workflow efficiency in smaller labs, doctor offices and decentralized lab settings such as point-of-care.
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Coagulation Monitor
CoaguChek Vantus

The CoaguChek Vantus is the first self-testing device for coagulation monitoring with built-in Bluetooth technology, allowing patients to use their tablet or smartphone with a compatible app to send their results automatically via wireless connectivity. The hand-held device includes several additional features to help patients with their self-testing, including medication and testing reminders, flagging of results in relation to the target range and the option to insert comments to the result.
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Screening Assays for Drugs of Abuse Testing
Hydrocodone (HYD), Buprenorphine (BUP), and 6-Acetylmorphine (6-AM) assays

The Hydrocodone (HYD), Buprenorphine (BUP), and 6-Acetylmorphine (6-AM) screening assays for drugs of abuse testing are now available on the cobas c 501 & 502 analyzers, allowing for quick response to growing testing demands due to the opioid epidemic. HYD and BUP are designed to detect specifically one parent drug and the main metabolite in human urine, while 6-AM detects the unique metabolite of heroin.
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Digital Slide Scanner
VENTANA DP 200

The VENTANA DP 200 is a six-slide, high-speed, brightfield scanner with excellent image quality to enhance pathologists’ review of digital slides. The slide scanner’s low-volume capacity is well-suited for first-time digital pathology users, remote site scanning, frozen section scanning, and more.
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Glucose Testing System
Accu-Chek Inform II

The Accu-Chek Inform II is a wireless-enabled hand-held system for point-of-care (POC) glucose testing and monitoring in hospitals with a fast measuring time of only five seconds using a small sample volume of 0.6 μL. It is approved for use with capillary, venous, arterial and neonatal blood and is designed to connect with the cobas POC IT 1000 solution to ensure that every test performed at the bedside of the patient is automatically recorded in their electronic medical record.
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Molecular Testing Platform
cobas 8800

The cobas 8800 is an integrated, fully automated molecular testing platform that can run up to 960 tests in an 8-hour shift—3,072 tests in 24 hours—with only three user interactions and up to four hours of walk-away time per run. It accepts primary and secondary uncapped tubes in standard five-position sample racks and is designed to be compatible with laboratory automation and conveying systems.
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NA Extraction System
MagNA Pure 24

The MagNA Pure 24 offers walkaway automation, minimal intervention, and extraction-to-extraction variability. It extracts NAs with a single universal reagent kit, along with on-board primary sample handling for low- to medium-throughput users who require high-quality NA extractions.
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Modular Chemistry Analyzer
cobas 8000

The cobas 8000 modular analyzer series can perform up to 680 immunoassay tests per hour and up to 9,800 clinical chemistry tests per hour, depending on the configurations. It offers over 100 configurations and up to 280 reagent channels to allow for tailored solutions in the areas of clinical chemistry, immunochemistry and serum work area testing.
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Blood Gas Analyzer
cobas b 221

The cobas b 221 blood gas analyzer delivers lab-quality results in less than two minutes and offers a comprehensive testing menu covers 18 of the most important critical-care blood parameters. The benchtop analyzer has a throughput of up to 50 samples per hour, is easy to handle and requires minimal preventative maintenance.
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Coagulation Analyzer
Coasys Plus C

The Coasys Plus C is a fully-automated random access coagulation analyzer for a routine menu of clotting, chromogenic and immunological coagulation tests. With a capacity of approximately 100 tests per hour with cap piercing, it is ideal for laboratories with a low to medium throughput of coagulation tests.
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Immunoassay System
cobas e 801

The cobas e 801 module is the newest member of the cobas 8000 modular analyzer series and offers more than 100 immunoassays across a wide range of disease areas, while allowing for continuous loading of reagents and consumables. Up to four cobas e 801 modules can be configured in series, delivering up to 1,200 tests per hour across up to 192 reagent positions, with a turn-around time of 18 minutes for routine and 9 minutes for emergency tests.
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Clinical Chemistry Analyzer
COBAS INTEGRA 400 plus

The COBAS INTEGRA 400 plus is a compact tabletop analyzer offering a broad test menu comprising over 120 assays and applications, including clinical chemistry, specific proteins, therapeutic drug monitoring, drug of abuse testing and whole blood HbA1c. It is an ideal solution for laboratories with a throughput of 25,000 to 250,000 tests per year or 50 to 250 samples per day.
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Nucleic Acid Extraction System
MagNA Pure 24 System

The MagNA Pure 24 System is a fully-automated clinical nucleic acid extraction system that offers walkaway automation, minimum user intervention, and extraction-to-extraction variability. It is capable of extracting nucleic acids from a wide range of human sample types with a single universal reagent kit, along with on-board primary sample handling for low to medium throughput users who require high quality nucleic acid extractions.
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Hematology Analyzer
cobas m 511

The cobas m 511 is an integrated hematology analyzer that combines a digital morphology analyzer, cell counter and classifier into one streamlined instrument preparing, staining and analyzing microscopy blood slides. It can identify, count, isolate and categorize white blood cells, red blood cells and platelets, and then present the digital images of all these cell types, including cell-by-cell images to eliminate the need for microscopic review.
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Automated DNA/RNA Purification System
MagNA Pure 96 System

The MagNA Pure 96 System is a fully automated, ultra-fast system that purifies DNA, RNA, and viral nucleic acids from a wide range of starting materials using magnetic glass particle technology. It process up to 96 samples in less than an hour using bar-coded, prefilled trays with ready-to-use reagents.
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Influenza A and B Virus Test
cobas Influenza A/B and RSV Assay

The cobas Influenza A/B and RSV nucleic acid test is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus and respiratory syncytial virus RNA. It analyzes nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection and is meant for use on the cobas Liat System.
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HIV-1 RN Test
cobas HIV-1

The cobas HIV-1 is an in vitro nucleic acid amplification test for the quantitation of HIV-1 in EDTA plasma of HIV-1-infected individuals and is meant for use on the cobas 6800/8800 system. It targets the gag and LTR regions of the HIV-1 genome for improved genotype inclusivity, detects HIV-1 variants and potentially avoids under quantification.
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POC PT/INR Testing Meter
CoaguChek XS Pro meter

The CoaguChek XS Pro battery-powered, handheld meter measures PT/INR values in approximately 1 minute with a drop of capillary blood (8 µL) and provides on-the-spot results without venous sampling. Its integrated barcode scanner captures patient and operator IDs, and it is ideal for testing INR at the hospital Point of Need and mid- to high-volume clinical settings.
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Automated Staining System
VENTANA HE 600

The VENTANA HE 600 fully automated hematoxylin and eosin (H&E) tissue staining system delivers fresh reagents on each individual slide without relying on user-supplied alcohol and deionized (DI) water. It offers more than 400 individual staining protocols and is fully customizable, allowing for laboratory and pathologists’ preferences and tissue variables.
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Automated HbA1c Analyzer
cobas c 513

The cobas c 513 fully automated HbA1c analyzer delivers up to 400 patient results per hour and has a high test capacity on board of 14,000 determinations. It requires minimum operator intervention from sample registration to result delivery, and its closed tube sampling function delivers maximum safety to the operator.
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Coagulation Meter
CoaguChek Pro II

The CoaguChek Pro II Coagulation Meter features a 2-D barcode reader for patient, operator and controls identification to enable faster ID entry, and offers enhanced connectivity through wireless technology and/or the unique QR code feature. It provides PT/INR results in approximately one minute, with side and top dosing options using a drop of venous, capillary or arterial fresh whole blood.
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PCR System
cobas LIAT

The cobas Liat system real-time PCR system for on-demand STAT testing can be used at satellite locations within a healthcare organization. The system automates the entire testing process from sample prep to amplification to real-time detection with results in 20 minutes or less.
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Diagnostic Test
cobas KRAS

The cobas KRAS Mutation Test is a TaqMelt assay intended for the detection of mutations in codons 12 and 13 of the KRAS gene. The PCR-based test is performed on the cobas 4800 system in less than eight hours, so physicians can make treatment decisions quickly and confidently.
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Urine Analyzer
cobas u 601

The cobas u 601 is designed as a fully automated solution for urine strip testing. The urine analyzer delivers high-quality and accurate results through reagent test strips, and is considered an ideal option for mid- to high-volume laboratories.
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HPV Test
cobas HPV test

The Cobas HPV test is a qualitative multiplex assay that detects 14 high-risk HPV types, while providing specific genotyping information for HPV types 16 and 18, the types responsible for about 70% of cervical cancer. The test is easy to use, and automated for the Cobas 4800 system.
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