American Bio-Reagents, Inc.
Country not established
- Devices
- 1
What American Bio-Reagents, Inc. makes
American Bio-Reagents, Inc. manufactures the FANA 60, a diagnostic reagent used for detecting antibodies in serum samples, primarily for autoimmune disease testing.
The FANA 60 is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Fana 60 Ref K854314
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Bio-Reagents, Inc. have in the registry?
The registry currently lists 1 device for American Bio-Reagents, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Bio-Reagents, Inc.'s devices?
Among its 1 most recently registered device, American Bio-Reagents, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do American Bio-Reagents, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for American Bio-Reagents, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Bio-Reagents, Inc. in the registry?
The most recently registered devices listed for American Bio-Reagents, Inc. include FANA 60.