Bioclinical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Bioclinical Systems, Inc. makes
Bioclinical Systems, Inc. produces diagnostic test kits and microbiological culture media, including enzyme immunoassay (EIA) and monoclonal antibody-based assays for theophylline, human chorionic gonadotropin (HCG), human leukocyte antigen (HLH), glucose, potassium, thyroid-stimulating hormone (TSH), and home pregnancy testing. The company also supplies specialized culture media for antimicrobial susceptibility testing, such as Mueller Hinton and chocolate agar, as well as selective agars for isolating pathogens like *Neisseria*. Visual readout test kits (e.g., Visi-Check) are part of its portfolio.
These products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. The company’s offerings are listed in the FDA’s 510(k) clearance registry. Bioclinical Systems, Inc. is based in the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Bioclinical Systems, Inc. have in the registry?
The registry currently lists 13 devices for Bioclinical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioclinical Systems, Inc.'s devices?
Among its 13 most recently registered devices, Bioclinical Systems, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Bioclinical Systems, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Bioclinical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioclinical Systems, Inc. in the registry?
The most recently registered devices listed for Bioclinical Systems, Inc. include MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL, NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG, MICRO-ELISA HLH TEST KIT MONOCLONAL and BCS GLUCOSE COLORIMETRIC TEST.