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Sekisui Diagnostics

Sekisui Diagnostics

For 40 years SEKISUI Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market through our sales channels and our distribution/business partners. Our product lines include clinica ...
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Covid-19 Sekisui Diagnostics

Clinical Laboratory

Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test

The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It simultaneously detects and differentiates between COVID-19, Flu A, and Flu B from only one sample, allowing healthcare providers to make more informed decisions when treating patients who are symptomatic for common viral infections.
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COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test

The OSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset. The product is available only in the USA.
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Point-Of-Care Testing

Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test

The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It simultaneously detects and differentiates between COVID-19, Flu A, and Flu B from only one sample, allowing healthcare providers to make more informed decisions when treating patients who are symptomatic for common viral infections.
More details

COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test

The OSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset. The product is available only in the USA.
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About Sekisui Diagnostics

Number of Employees: 400-999
Year of Establishment: 2011
For 40 years SEKISUI Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market through our sales channels and our distribution/business partners. Our product lines include clinical chemistry reagents, point-of-care, rapid tests as well as enzymes and specialty biochemicals.

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C-Reactive Protein Reagent
CRP Ultra Wide Range Reagent Kit

The CRP Ultra Wide Range Reagent Kit is intended for the quantitative measurement of C-reactive protein in human serum by immunoturbidimetry. The measurement of CRP aids in the detection and evaluation of infection, tissue injury, and inflammatory disorders.
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Fentanyl Assay
ARK Fentanyl Assay

The ARK Fentanyl Assay is intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl with its sensitivity and specificity providing confidence in the results.
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RPR and TPLA Assays
SEKURE RPR and TPLA Assays

The SEKURE RPR and TPLA assays are intended for the quantitative measurement of syphilitic anti-lipid antibody concentration in serum and plasma. Its fully automated methodology improves the accuracy, precision, and consistency of results which are delivered in 10 minutes, making it ideal for screening.
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Clinical Laboratory

C-Reactive Protein Reagent
CRP Ultra Wide Range Reagent Kit

The CRP Ultra Wide Range Reagent Kit is intended for the quantitative measurement of C-reactive protein in human serum by immunoturbidimetry. The measurement of CRP aids in the detection and evaluation of infection, tissue injury, and inflammatory disorders.
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Fentanyl Assay
ARK Fentanyl Assay

The ARK Fentanyl Assay is intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl with its sensitivity and specificity providing confidence in the results.
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RPR and TPLA Assays
SEKURE RPR and TPLA Assays

The SEKURE RPR and TPLA assays are intended for the quantitative measurement of syphilitic anti-lipid antibody concentration in serum and plasma. Its fully automated methodology improves the accuracy, precision, and consistency of results which are delivered in 10 minutes, making it ideal for screening.
More details

Enzymatic Creatinine Assay
SEKISUI Enzymatic Creatinine Assay

The SEKISUI Enzymatic Creatinine assay accurately measures creatinine levels in serum, plasma, and urine by utilizing a multi-step approach ending with a photometric end-point reaction. The assay is easy to use with no additional preparation required and ensures high reliability of testing and confidence in results.
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Cholesterol Assay
SEKISUI Cholesterol-SL Assay

SEKISUI Cholesterol-SL assay is intended for the in vitro quantitative measurement of total cholesterol in serum. The assay employs an enzymatic method using cholesterol esterase and cholesterol oxidase as reliable determinants for the quantitative measurement of cholesterol in serum.
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Bilirubin-SL Assay
SEKISUI Direct Bilirubin-SL Assay

The SEKISUI Direct Bilirubin-SL assay is intended for the in vitro quantitative measurement of direct bilirubin concentration in serum. Elevated serum bilirubin is indicative of impairment of the liver, excessive hemolysis, or obstruction of the biliary tract.
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Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test

The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It simultaneously detects and differentiates between COVID-19, Flu A, and Flu B from only one sample, allowing healthcare providers to make more informed decisions when treating patients who are symptomatic for common viral infections.
More details

COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test

The OSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset. The product is available only in the USA.
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Diagnostic Reader
Acucy System

The Acucy System comprising the Acucy Diagnostic Reader with printer provides clinicians flexibility in workflow and accurate, standardized results for improved patient care. Used with the Acucy Influenza A&B Test, it provides best-in-class Flu A performance when compared to immunoassay products in the market.
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Fentanyl Urine Test
ARK Fentanyl Assay

The ARK Fentanyl Assay is intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1 ng/mL. The assay offers a simple and rapid analytical screening procedure for detecting fentanyl with its high sensitivity and specificity offering confidence in results.
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hCG Card Pregnancy Test
OSOM hCG Card Pregnancy Test

The OSOM hCG Card Pregnancy Test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early determination of pregnancy. The test offers increased sensitivity and easy-to-read black on white results in just three minutes.
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hCG Urine Test
OSOM hCG Urine Test

The OSOM hCG Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The economical test with 25mIU/mL sensitivity delivers easy-to-read two-color results in five minutes or less.
More details

Group A Streptococcus Antigen Test
OSOM Strep A Test

The OSOM Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. It delivers easy-to-read two color results in five minutes.
More details

Human Chorionic Gonadotropin (hCG) Test
OSOM hCG Combo Test

The OSOM hCG Combo Test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy. It provides easy-to-read black on white results within three minutes for urine and five minutes for serum.
More details

Bacterial Vaginosis Test
OSOM BVBLUE Test

The OSOM BVBLUE Test detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. Instant color change provides clear easy-to-read results with a one minute hands-on-time and 10 minutes read time.
More details

Mononucleosis Heterophilic Antibody Test
OSOM Mono Test

The OSOM Mono Test is intended for the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood. It delivers easy-to-read two color results in five minutes, and has >99% sensitivity and 96% specificity.
More details

RSV/Adenovirus Test
OSOM RSV/Adeno Test

The OSOM RSV/Adeno test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) and/or Adenovirus antigens directly from nasal swabs or nasal suction fluid in patients suspected of having a viral respiratory infection. Throat swabs are also an acceptable sample type for the detection of Adenovirus antigens.
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Calibration/Linearity Material
DC-Lineate

DC-lineate is a tri-level calibration/ linearity material intended for use with the UIBC assay. The calibration/linearity material is stable at 2-8°C for 14 days.
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Creatine Kinase Reagent
CREATINE KINASE (CK)-SL

The CREATINE KINASE (CK)-SL is a two part, stable liquid ready-to-use reagent for the measurement of creatine kinase and does not require additional reagent preparation. It has a wide linear range, reducing repeat testing and the need for sample dilutions, and does not display significant interference from samples with elevated levels of icterus or lipemia.
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Clinical Chemistry Reagents
SEKURE Clinical Chemistry Reagents

SEKURE Clinical Chemistry Reagents feature liquid stable technology, exceptional performance, proven reliability, flexible packaging, and a wide range of supporting products and services.
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Flu A&B Test
OSOM® Ultra Plus Flu A&B Test

The OSOM® Ultra Plus Flu A&B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab and nasopharyngeal swab specimens obtained from patients with signs and symptoms of respiratory infection.
More details

Influenza A&B Test
Acucy Influenza A&B

The Acucy Influenza A&B test allows provided fast and accurate results that aid in the treatment of a patient in one office visit, enhancing the patient experience, reducing the spread of infection and improving patient care. It offers Read Now or Walk Away mode and provides results within 15 minutes using a CLIA-waived procedure.
More details

H. pylori Test
OSOM H. pylori Test

The OSOM H. pylori Test is intended for the qualitative detection of H. pylori antibodies in serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection. It provides easy-to-read results in 10 minutes or less and has 95.9% sensitivity versus biopsy/histology.
More details

Flu A & B Test
OSOM Ultra Flu A & B Test

The OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens. Using a simple five step CLIA-waived procedure with pre-measured extraction buffer for swab samples, it provides accurate, differentiated interpretation of results in 10-15 minutes.
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iFOB Test
OSOM iFOB Test

The OSOM iFOB Test is a rapid qualitative test for the immunochemical detection of fecal occult blood/human hemoglobin (hHb) in human fecal specimens. It is used as an aid in the diagnosis of gastrointestinal disorders such as diverticulitis, colitis, polyps, and colorectal cancer.
More details

Trichomonas Test
OSOM Trichomonas Test

The OSOM Trichomonas Test is the only CLIA-waived rapid test for the detection of Trichomoniasis vaginalis that detects the antigen without the need for live organism. It provides objective easy-to-read two-color results in 10 minutes or less along with reduced hands-on time, significantly decreasing the amount of labor devoted to microscopy.
More details

Immunoassay Test
OSOM Ultra hCG Combo Test

The OSOM Ultra hCG Combo Test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. It requires a single step procedure with
More details

Group A Streptococcus Test
OSOM Ultra Strep A Test

The OSOM Ultra Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. It provides easy-to-read two color results in five minutes and includes two additional test sticks for external QC testing (50 test kit).
More details

HbA1c Assay
SEKURE HbA1c assay

The SEKURE HbA1c assay is an enzymatic assay that is used in clinical laboratories to measure the percent concentration of HbA1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate. It is an enzymatic assay which is NGSP certified and utilizes an onboard pretreatment step on Sekisui Diagnostics SK 500 Clinical Chemistry System, eliminating time-consuming manual preparation prior to testing.
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Point-Of-Care Testing

Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test

The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It simultaneously detects and differentiates between COVID-19, Flu A, and Flu B from only one sample, allowing healthcare providers to make more informed decisions when treating patients who are symptomatic for common viral infections.
More details

COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test

The OSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset. The product is available only in the USA.
More details

hCG Card Pregnancy Test
OSOM hCG Card Pregnancy Test

The OSOM hCG Card Pregnancy Test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early determination of pregnancy. The test offers increased sensitivity and easy-to-read black on white results in just three minutes.
More details

hCG Urine Test
OSOM hCG Urine Test

The OSOM hCG Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The economical test with 25mIU/mL sensitivity delivers easy-to-read two-color results in five minutes or less.
More details

Group A Streptococcus Antigen Test
OSOM Strep A Test

The OSOM Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. It delivers easy-to-read two color results in five minutes.
More details

Human Chorionic Gonadotropin (hCG) Test
OSOM hCG Combo Test

The OSOM hCG Combo Test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy. It provides easy-to-read black on white results within three minutes for urine and five minutes for serum.
More details

Bacterial Vaginosis Test
OSOM BVBLUE Test

The OSOM BVBLUE Test detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. Instant color change provides clear easy-to-read results with a one minute hands-on-time and 10 minutes read time.
More details

Mononucleosis Heterophilic Antibody Test
OSOM Mono Test

The OSOM Mono Test is intended for the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood. It delivers easy-to-read two color results in five minutes, and has >99% sensitivity and 96% specificity.
More details

RSV/Adenovirus Test
OSOM RSV/Adeno Test

The OSOM RSV/Adeno test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) and/or Adenovirus antigens directly from nasal swabs or nasal suction fluid in patients suspected of having a viral respiratory infection. Throat swabs are also an acceptable sample type for the detection of Adenovirus antigens.
More details

Flu A&B Test
OSOM® Ultra Plus Flu A&B Test

The OSOM® Ultra Plus Flu A&B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab and nasopharyngeal swab specimens obtained from patients with signs and symptoms of respiratory infection.
More details

Influenza A&B Test
Acucy Influenza A&B

The Acucy Influenza A&B test allows provided fast and accurate results that aid in the treatment of a patient in one office visit, enhancing the patient experience, reducing the spread of infection and improving patient care. It offers Read Now or Walk Away mode and provides results within 15 minutes using a CLIA-waived procedure.
More details

H. pylori Test
OSOM H. pylori Test

The OSOM H. pylori Test is intended for the qualitative detection of H. pylori antibodies in serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection. It provides easy-to-read results in 10 minutes or less and has 95.9% sensitivity versus biopsy/histology.
More details

iFOB Test
OSOM iFOB Test

The OSOM iFOB Test is a rapid qualitative test for the immunochemical detection of fecal occult blood/human hemoglobin (hHb) in human fecal specimens. It is used as an aid in the diagnosis of gastrointestinal disorders such as diverticulitis, colitis, polyps, and colorectal cancer.
More details

Trichomonas Test
OSOM Trichomonas Test

The OSOM Trichomonas Test is the only CLIA-waived rapid test for the detection of Trichomoniasis vaginalis that detects the antigen without the need for live organism. It provides objective easy-to-read two-color results in 10 minutes or less along with reduced hands-on time, significantly decreasing the amount of labor devoted to microscopy.
More details

Group A Streptococcus Test
OSOM Ultra Strep A Test

The OSOM Ultra Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. It provides easy-to-read two color results in five minutes and includes two additional test sticks for external QC testing (50 test kit).
More details
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