Chembio Diagnostic Systems, Inc.

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Web: http://www.chembio.com
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Address: 3661 Horseblock Road, Medford, New York 11763, USA
Phone: +1-(631)-924-1135 | Fax: +1-(631)-924 6033 | Map/Directions >>

Profile: Chembio Diagnostic Systems, Inc. develops and manufactures point-of-care (POC) diagnostic tests and technology for infectious diseases. Our products serve diverse markets that are global. We also export our products to various countries worldwide. We develop a new and innovative chromatographic immunoassay technology dual path platform (DPP®) for rapid, point-of-care diagnostic testing of a wide variety of analysts. This technology offers significant advantages over lateral flow technology. Our products include single analyte, multiplex and confirmatory assays for a number of infectious diseases including TB, and other infectious diseases.

FDA Registration Number: 2431980

28 Products/Services (Click for related suppliers)

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660)

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Borrelia Serological Reagent (FDA Code: LSR / 866.3830)

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Chlamydia Trachomatis (FDA Code: MGM / 866.3120)

Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

• Chlamydia trachomatis IgA ELISA Kit

• Chlamydia trachomatis IgG ELISA Kit

• Chlamydia Trachomatis IgG Kit

• Chlamydia trachomatis IgM ELISA Kit

• Chlamydia Trachomatis Real Time PCR Kit

• Equine Encephalitis Virus CF Antisera (FDA Code: GQC / 866.3240)

Equine encephalomyelitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antobodies to equine encephalomyelitis virus in serum. The identification aids in the diagnosis of diseases caused by equine encephalomyelitis viruses and provides epidemiological information on these viruses. Equine encephalomyelitis viruses are transmitted to humans by the bite of insects, such as mosquitos and ticks, and may cause encephalitis (inflammation of the brain), rash, acute arthritis, or hepatitis.

• Hemoglobin Control (FDA Code: GGM / 864.8625)

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

• Hepatitis B Test (FDA Code: LOM)

• HIV Detection Test (FDA Code: MZF)

• HIV Rapid Test Control Packs

• HIV-1&2 Saliva Test Kit (FDA Code: MWB)

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485)

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

• Mycobacterium Tuberculosis Complex Nucleic Acid Amplification System (FDA Code: MWA / 866.3372)

• Mycobacterium Tuberculosis Fluorescent Antiserum Test (FDA Code: GRT / 866.3370)

• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 866.6010)

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

• Respiratory Syncytial Virus - Elisa (FDA Code: MCE / 866.3480)

Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.

• Rotavirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LIQ / 866.3405)

Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.

• Serum Human Chorionic Gonadotropin Test (FDA Code: DHA / 862.1155)

• Sickle Cell Test (FDA Code: GHM / 864.7825)

A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740)

• T.Cruzi Enzyme Linked Immunoabsorbent Assay (FDA Code: MIU / 866.3870)

• Treponema Pallidum Enzyme Linked Immunoabsorbent Assay (FDA Code: LIP / 866.3830)

• Troponin Subunit Enzymatic Method (FDA Code: MMI / 862.1215)

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.