Progenika Biopharma S.A., A Grifols Company
SpainFDA applicant, unverified
- Devices
- 4
What Progenika Biopharma S.A., A Grifols Company makes
Progenika Biopharma S.A. manufactures genetic testing devices, including the A1AT Genotyping Test for identifying alpha-1 antitrypsin (A1AT) genetic variants, and the AlphaID™ At Home service for assessing genetic health risk via at-home testing.
These products are classified as Class II medical devices and have been submitted for 510(k) clearance with the FDA. The company is based in Spain.
Catalogue
A1AT Genotyping Test Ref K192858
Regimes: 510(k) Registry: 510(k)A1AT Genotyping Test Ref K171868
Regimes: 510(k) Registry: 510(k)A1AT Genotyping Test Ref K211115
Regimes: CE IVDR 510(k) Registry: 510(k)AlphaID™ At Home Genetic Health Risk Service Ref K221420
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Progenika Biopharma S.A., A Grifols Company have in the registry?
The registry currently lists 4 devices for Progenika Biopharma S.A., A Grifols Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Progenika Biopharma S.A., A Grifols Company's devices?
Among its 4 most recently registered devices, Progenika Biopharma S.A., A Grifols Company has devices listed in FDA 510(k) (4 devices).
What risk classes do Progenika Biopharma S.A., A Grifols Company's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Progenika Biopharma S.A., A Grifols Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Progenika Biopharma S.A., A Grifols Company in the registry?
The most recently registered devices listed for Progenika Biopharma S.A., A Grifols Company include A1AT Genotyping Test and AlphaID™ At Home Genetic Health Risk Service.