Biotrax, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Biotrax, Inc. makes
Biotrax, Inc. manufactures diagnostic tests for infectious diseases and autoimmune markers, including the CROMATEST Syphilis Diagnostic and CROMATEST Rheumatoid Diagnostic variants (CRP Latex, RF Latex, and standalone Rheumatoid). These products use latex agglutination and other immunoassay methods for detecting specific antibodies or antigens in patient samples.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with authorisations recorded via the 510(k) pathway. Products are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
Cromatest Syphilis Diagnostic Ref K904496
Regimes: 510(k) Registry: 510(k)Cromatest Rheumatoid Diagnostic/Crp Latex Test Ref K904497
Regimes: 510(k) Registry: 510(k)Cromatest Rheumatoid Diagnostic/Rf Latex Test Ref K904498
Regimes: 510(k) Registry: 510(k)Croatest (R) Rheumatoid Diagnostic Ref K904416
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotrax, Inc. have in the registry?
The registry currently lists 4 devices for Biotrax, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotrax, Inc.'s devices?
Among its 4 most recently registered devices, Biotrax, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Biotrax, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biotrax, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotrax, Inc. in the registry?
The most recently registered devices listed for Biotrax, Inc. include CROMATEST SYPHILIS DIAGNOSTIC, CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST, CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST and CROATEST (R) RHEUMATOID DIAGNOSTIC.