Biostar, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Biostar, Inc. makes
Biostar, Inc. makes diagnostic test devices for detecting infectious agents, including Streptococcus A, Streptococcus B, Chlamydia, influenza A and B, and Clostridium difficile toxin A, using optical immunoassay technology.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Strep A Oia Max Ref K962060
Regimes: 510(k) Registry: 510(k)Chlamydia Oia Ref K951010
Regimes: 510(k) Registry: 510(k)Strep B Oia Ref K936112
Regimes: 510(k) Registry: 510(k)Ab Flu Oia Ref K981651
Regimes: 510(k) Registry: 510(k)Strep B Oia Ref K991828
Regimes: 510(k) Registry: 510(k)Cdtox A Oia Ref K991829
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biostar, Inc. have in the registry?
The registry currently lists 6 devices for Biostar, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biostar, Inc.'s devices?
Among its 6 most recently registered devices, Biostar, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biostar, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biostar, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biostar, Inc. in the registry?
The most recently registered devices listed for Biostar, Inc. include STREP A OIA MAX, CHLAMYDIA OIA, STREP B OIA and AB FLU OIA.