Contract manufacturerGrifols Diagnostic Solutions Inc. (San Diego, CA)CaliforniaHematologyMicrobiologyClass IINot classified
Grifols Diagnostic Solutions Inc.
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2032600 (openFDA record; or search FDA's registration database)
- FEI number
- 3003460312
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- Grifols Diagnostic Solutions Inc. (FDA owner/operator no. 10051675)
- Registered address
- 10808 WILLOW CT., San Diego, CA 92127
- Contract listings
- 5 device listings, 5 product codes, first listed May 11, 2018
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Class II | Hematology | Contract manufacturing | Aug 15, 2025 |
| MZF | Test, Hiv Detection | Class II | Microbiology | Contract manufacturing | May 11, 2018 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Class II | Microbiology | Contract manufacturing | Aug 30, 2018 |
| PFK | Quality Control For Molecular Immunohematology Tests | Class II | Hematology | Contract manufacturing | Jun 20, 2025 |
| POA | Reagents, Zika Virus Nucleic Acid | Not classified | Microbiology | Contract manufacturing | Nov 9, 2018 |