Osmetech Molecular Diagnostics
Country not established
- Devices
- 3
What Osmetech Molecular Diagnostics makes
Osmetech Molecular Diagnostics manufactures the eSensor system and XT-8 instrument, which are used for molecular diagnostic testing. Their product portfolio includes genotyping tests for warfarin sensitivity, cystic fibrosis, and specific genetic markers such as FII, FV, and MTHFR.
The company is based in the United States, and its devices are classified as Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.
Catalogue
Esensor Warfarin Sensitivity And Xt-8 Instrument Ref K073720
Regimes: 510(k) Registry: 510(k)Esenor Fii-Fv-Mthfr Genotyping Test, Esenor Fii-Fv Genotyping Test, Esenor Fii Genotyping Ref K093974
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Osmetech Molecular Diagnostics have in the registry?
The registry currently lists 3 devices for Osmetech Molecular Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osmetech Molecular Diagnostics's devices?
Among its 3 most recently registered devices, Osmetech Molecular Diagnostics has devices listed in FDA 510(k) (3 devices).
What risk classes do Osmetech Molecular Diagnostics's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Osmetech Molecular Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osmetech Molecular Diagnostics in the registry?
The most recently registered devices listed for Osmetech Molecular Diagnostics include ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT, ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING and ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8.