Oxoid Limited (Part of Thermo Fisher Scientific)
United KingdomFDA applicant, unverified
- Devices
- 7
What Oxoid Limited (Part of Thermo Fisher Scientific) makes
Oxoid Limited manufactures antimicrobial susceptibility test discs for identifying bacterial resistance to specific antibiotics, including rezafungin, omadacycline, meropenem/vaborbactam, lefamulin, eravacycline, sulbactam/durlobactam, and cefiderocol. These discs are designed for use in microbiology laboratories to evaluate the effectiveness of antibiotics against isolated bacterial strains. The products support routine and research applications in infectious disease diagnostics.
The company’s antimicrobial discs are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry. Oxoid Limited operates as part of Thermo Fisher Scientific, with its headquarters based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oxoid Limited (Part of Thermo Fisher Scientific) have in the registry?
The registry currently lists 7 devices for Oxoid Limited (Part of Thermo Fisher Scientific). Devices recorded under merged duplicate company entries are counted once.
Which registries list Oxoid Limited (Part of Thermo Fisher Scientific)'s devices?
Among its 7 most recently registered devices, Oxoid Limited (Part of Thermo Fisher Scientific) has devices listed in FDA 510(k) (7 devices).
What risk classes do Oxoid Limited (Part of Thermo Fisher Scientific)'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Oxoid Limited (Part of Thermo Fisher Scientific)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oxoid Limited (Part of Thermo Fisher Scientific) in the registry?
The most recently registered devices listed for Oxoid Limited (Part of Thermo Fisher Scientific) include Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5, Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30, Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 and Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20.