Dynagen, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Dynagen, Inc. makes
Dynagen, Inc. manufactures diagnostic test kits and performance specimens for microbiological identification, including culture identification kits for *Mycobacterium kansasii*, *M. tuberculosis*, and *M. avium*, as well as urine test strips and control specimens for rapid diagnostic testing.
The company’s products are regulated under FDA Class I and Unclassified (U) devices, with several listed via the 510(k) pathway. These devices are intended for in vitro diagnostic use and are based in the United States.
Catalogue
Niccheck I Ref K963733
510(k) 510(k)Procheck(Tm) Blind Performance Specimens Ref K931105
510(k) 510(k)Mycoakt M Kansasii Culture Id Kit Ref K943050
510(k) 510(k)Mycoakt M. Tuberculosis Cuulture Id Kit Ref K943051
510(k) 510(k)- 510(k) 510(k)
Mycoakt M. Avium Culture Id Kit Ref K943049
510(k) 510(k)
Frequently asked questions
How many devices does Dynagen, Inc. have in the registry?
The registry currently lists 6 devices for Dynagen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dynagen, Inc.'s devices?
Among its 6 most recently registered devices, Dynagen, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Dynagen, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Dynagen, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dynagen, Inc. in the registry?
The most recently registered devices listed for Dynagen, Inc. include NICCHECK I, PROCHECK(TM) BLIND PERFORMANCE SPECIMENS, MYCOAKT M KANSASII CULTURE ID KIT and MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT.