Alfa Biotech (UK), Ltd.
United KingdomFDA applicant, unverified
- Devices
- 3
What Alfa Biotech (UK), Ltd. makes
Alfa Biotech (Uk), Ltd. manufactures in vitro diagnostic test kits and associated calibrator packs for the measurement of thyroid-stimulating hormone, ferritin, and free triiodothyronine. These products include the AURAFLEX TSH-3, AURAFLEX FERRITIN, and AURAFLEX FT3 test and calibrator packs.
The company is based in the US, and its portfolio consists of Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.
Catalogue
- 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 Alfa Biotech (Uk), Ltd. have in the registry?
The registry currently lists 3 devices for Alfa Biotech (Uk), Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alfa Biotech (Uk), Ltd.'s devices?
Among its 3 most recently registered devices, Alfa Biotech (Uk), Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Alfa Biotech (Uk), Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Alfa Biotech (Uk), Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alfa Biotech (Uk), Ltd. in the registry?
The most recently registered devices listed for Alfa Biotech (Uk), Ltd. include AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0, AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 and AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK.