Biosite Incorporated
United StatesFDA applicant, unverified
- Devices
- 46
What Biosite Incorporated makes
Biosite Incorporated manufactures rapid diagnostic tests for detecting drugs of abuse, cardiac biomarkers, and natriuretic peptides. Their products include point-of-care panels for troponin-I, CK-MB, myoglobin, and BNP, as well as individual test strips for substances like methadone metabolites and opiates. They also supply calibration and control materials for cardiac and toxicology screening assays.
The company’s diagnostic tests are authorised as Class I and Class II devices under FDA regulations, with many cleared via the 510(k) pathway. Their products are primarily listed in the FDA’s 510(k) registry, reflecting compliance with US medical device standards. The manufacturer is based in the United States.
Catalogue
Search and filter all 46 devicesFrequently asked questions
How many devices does Biosite Incorporated have in the registry?
The registry currently lists 46 devices for Biosite Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosite Incorporated's devices?
Among its 46 most recently registered devices, Biosite Incorporated has devices listed in FDA 510(k) (46 devices).
What risk classes do Biosite Incorporated's devices fall under?
Among its 46 most recently registered devices, the classes recorded for Biosite Incorporated's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosite Incorporated in the registry?
The most recently registered devices listed for Biosite Incorporated include BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML), TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I, MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST and ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP.