American Bionetics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What American Bionetics, Inc. makes
American Bionetics, Inc. manufactures diagnostic test systems for detecting respiratory syncytial virus (RSV) and other pathogens, including the WESBLOT RNP-SM test for rapid antigen detection, the WESBLOT Processor for automated analysis, and the VERSABLOT system for versatile pathogen testing.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These systems are listed in the FDA’s 510(k) database and are intended for use in clinical and point-of-care settings in the United States.
Catalogue
Wesblot Rnp-Sm Test Ref K881379
Regimes: 510(k) Registry: 510(k)Wesblot Processor Ref K874887
Regimes: 510(k) Registry: 510(k)Versablot Ref K884258
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Bionetics, Inc. have in the registry?
The registry currently lists 3 devices for American Bionetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Bionetics, Inc.'s devices?
Among its 3 most recently registered devices, American Bionetics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do American Bionetics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for American Bionetics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Bionetics, Inc. in the registry?
The most recently registered devices listed for American Bionetics, Inc. include WESBLOT RNP-SM TEST, WESBLOT PROCESSOR and VERSABLOT.