Profile: Biosite Incorporated is a bio-medical company commercializing proteomics discoveries for the advancement of medical diagnosis. We offer products such as drug testing, cardiovascular diseases, infectious diseases, cerebrovascular diseases & thromboembolic diseases. Our triage tox drug screen is a fluorescence immunoassay intended to be used with the triage meterplus, which simultaneously detects eight classes of commonly abused drugs in approximately fifteen minutes. Our triage cardiac panel aids in the diagnosis of acute myocardial infarction.
FDA Registration Number: 2027969
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• POC Rapid Cardiac Markers |
• POCT Data Management Systems |
• Point-of-Care Data System |
• Point-of-care Manager Data Workstation |
• Profiler Shortness of Breath Panel |
• Propoxyphene Enzyme Immunoassay (FDA Code: JXN / 862.3700) A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy. |
• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290) A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene). |
• Secondary Calibrator (FDA Code: JIT / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.) |
• Software Programs |
• Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (FDA Code: MLK / 862.3910) A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy. |
• TOX Drug Screen |
• Water-microbiology kit |