FDA Registration
Active
🇪🇸 Spain
PROGENIKA BIOPHARMA S.A.
Reg #: 3006413195
·
FEI: 3006413195
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- PROGENIKA BIOPHARMA S.A.
- Registration Number
- 3006413195
- FEI Number
- 3006413195
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia
- City
- Derio Vizcaya
- Country
- ES
Regulatory Submissions
- 510(k) Number
- BK170092
- PMA Number
- BP170154
Owner / Operator
- Firm Name
- Progenika Biopharma S.A.
- Operator Number
- 10056259
- Address
- Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia
- City
- Derio
- State
- Vizcaya
- Postal Code
- 48160
- Country
- ES
US Agent
- Business Name
- GRIFOLS
- Contact Name
- Alisha McReynolds
- Address
- 4560 Horton St.
- City
- Emeryville
- State
- CA
- ZIP
- 94608
- Country
- US
- [email protected]
- Phone
- 510 9235046
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Quality Control For Molecular Immunohematology Tests | PFK | Class 2 | Hematology | No | 2018-11-05 |
| Serpina1 Variant Detection System | PZH | Class 2 | Immunology | No | 2021-10-25 |
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2022-11-11 |
| Molecular Erythrocyte Typing Test | PEP | Class 3 | Unknown | No | 2018-11-05 |
| Genetic Variant Detection And Health Risk Assessment System | PTA | Class 2 | Immunology | No | 2022-11-08 |
Proprietary Names
ID CORE CONTROL
A1AT Genotyping Test
ORAcollectDx OCD-10014
ID CORE XT
AlphaID At Home Genetic Health Risk Service
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility