Grifols USA, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Grifols USA, LLC makes
Grifols USA, LLC manufactures diagnostic tests for celiac disease, including the Interlab IFE Test using G 26 Ver. 2.0 instrument for serological analysis and Gliadin IgA and Gliadin IgG assays to detect antibodies associated with gluten sensitivity.
These products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) clearance. The company operates within the United States.
Catalogue
Eu-Ttg Iga And Eu-Ttg Igg Ref K102964
Regimes: 510(k) Registry: 510(k)Interlab Ife Test Using G 26 Ver. 2.0 Instrument Ref K120169
Regimes: 510(k) Registry: 510(k)Gliadin Iga And Gliadin Lga Ref K113377
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Grifols USA, LLC have in the registry?
The registry currently lists 3 devices for Grifols USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Grifols USA, LLC's devices?
Among its 3 most recently registered devices, Grifols USA, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Grifols USA, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Grifols USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Grifols USA, LLC in the registry?
The most recently registered devices listed for Grifols USA, LLC include EU-TTG IGA AND EU-TTG IGG, INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT and GLIADIN IGA AND GLIADIN LGA.