Data / Medical devices / Spain / Progenika Biopharma S.A.
Progenika Biopharma S.A.: FDA-registered device maker in Derio Vizcaya, Spain, 3 510(k) clearances
Progenika Biopharma S.A. is registered with the FDA (registration 3006413195) in Derio Vizcaya, Spain. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 27, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006413195
- Address
- Ibaizabal bidea, Edificio 504 Parque Tecnologico de Bizkaia, Derio Vizcaya, Spain, 48160
- Owner or operator
- Progenika Biopharma S.A. (10056259)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 5, 2018
- Registered through
- 2027
- Brand names listed
- A1AT Genotyping Test, AlphaID At Home Genetic Health Risk Service, ID CORE CONTROL, ID CORE XT, ORAcollectDx OCD-10014
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dna Specimen Collection, Saliva | OYJ | 2 | Specification developer | accessdata.fda.gov |
| Genetic Variant Detection And Health Risk Assessment System | PTA | 2 | Manufacturer | accessdata.fda.gov |
| Molecular Erythrocyte Typing Test | PEP | 3 | Manufacturer | accessdata.fda.gov |
| Quality Control For Molecular Immunohematology Tests | PFK | 2 | Manufacturer | accessdata.fda.gov |
| Serpina1 Variant Detection System | PZH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2022 | K221420 | AlphaID At Home Genetic Health Risk Service | PTA | Substantially Equivalent | Progenika Biopharma S.A., A Grifols Company | accessdata.fda.gov |
| October 27, 2022 | K212745 | ORAcollect®Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| May 13, 2021 | K211115 | A1AT Genotyping Test | PZH | Substantially Equivalent | Progenika Biopharma S.A., A Grifols Company | accessdata.fda.gov |
Compare with other makers
- All makers of Quality Control For Molecular Immunohematology Tests
- All makers of Genetic Variant Detection And Health Risk Assessment System
- All makers of Dna Specimen Collection, Saliva
Updated October 27, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.