Thermo Fisher Scientific (Oxoid Ltd.)
United KingdomFDA applicant, unverified
- Devices
- 3
What Thermo Fisher Scientific (Oxoid Ltd.) makes
Thermo Fisher Scientific (Oxoid Ltd.) manufactures antimicrobial susceptibility test discs, including those for gepotidacin and aztreonam/avibactam, used to determine bacterial resistance patterns in clinical microbiology labs.
These products are regulated as Class II medical devices under the FDA’s 510(k) clearance pathway and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: CE IVDR 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Thermo Fisher Scientific (Oxoid Ltd.) have in the registry?
The registry currently lists 3 devices for Thermo Fisher Scientific (Oxoid Ltd.). Devices recorded under merged duplicate company entries are counted once.
Which registries list Thermo Fisher Scientific (Oxoid Ltd.)'s devices?
Among its 3 most recently registered devices, Thermo Fisher Scientific (Oxoid Ltd.) has devices listed in FDA 510(k) (3 devices).
What risk classes do Thermo Fisher Scientific (Oxoid Ltd.)'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Thermo Fisher Scientific (Oxoid Ltd.)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Thermo Fisher Scientific (Oxoid Ltd.) in the registry?
The most recently registered devices listed for Thermo Fisher Scientific (Oxoid Ltd.) include Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60, Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 and Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50.