Phoenix Biotech Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Phoenix Biotech Corp. makes
Phoenix Biotech Corp. manufactures in vitro diagnostic tests for detecting treponemal antibodies, including the TREPCHEK and TREP-SURE Treponemal Antibody EIA assays. These tests are designed for use in serological screening and confirmation of syphilis infections.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. These tests are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Trepchek Treponemal Antibody Eia Ref K001552
Regimes: 510(k) Registry: 510(k)Trep-Sure Treponemal Antibody Eia Ref K053570
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Phoenix Biotech Corp. have in the registry?
The registry currently lists 2 devices for Phoenix Biotech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phoenix Biotech Corp.'s devices?
Among its 2 most recently registered devices, Phoenix Biotech Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Phoenix Biotech Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Phoenix Biotech Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Phoenix Biotech Corp. in the registry?
The most recently registered devices listed for Phoenix Biotech Corp. include TREPCHEK TREPONEMAL ANTIBODY EIA and TREP-SURE TREPONEMAL ANTIBODY EIA.