Ab Biodisk North America, Inc.
Country not established
- Devices
- 3
What Ab Biodisk North America, Inc. makes
Ab Biodisk North America, Inc. manufactures antimicrobial susceptibility testing products, including pre-poured antibiotic gradient strips like amoxicillin/clavulanic acid (2/1) and ampicillin/sulbactam (2/1), as well as automated systems such as the U3 system for gentamicin testing. These tools are designed for microbiology laboratories to determine bacterial resistance profiles.
The company’s products fall under FDA Class II medical devices and are authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Amoxicillin/Clavulanic Acid 2/1 Ref K950328
Regimes: 510(k) Registry: 510(k)Etest For Ampicillin/Sulbactam 2/1 Ref K935519
Regimes: 510(k) Registry: 510(k)System U3 For Gentamicin Ref K983252
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ab Biodisk North America, Inc. have in the registry?
The registry currently lists 3 devices for Ab Biodisk North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ab Biodisk North America, Inc.'s devices?
Among its 3 most recently registered devices, Ab Biodisk North America, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Ab Biodisk North America, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ab Biodisk North America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ab Biodisk North America, Inc. in the registry?
The most recently registered devices listed for Ab Biodisk North America, Inc. include AMOXICILLIN/CLAVULANIC ACID 2/1, ETEST FOR AMPICILLIN/SULBACTAM 2/1 and SYSTEM U3 FOR GENTAMICIN.