Contract manufacturerDIASORIN INC. (Stillwater, MN)MinnesotaImmunologyClinical chemistryMicrobiologyClass IIClass IClass III
DIASORIN INC.
Contract manufacturer ยท Stillwater, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2182595 (openFDA record; or search FDA's registration database)
- FEI number
- 2182595
- Registered for
- FDA registration year 2027
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- DiaSorin Inc. (FDA owner/operator no. 9051149)
- Registered address
- 1951 Northwestern Ave, Stillwater, MN 55082
- Contract listings
- 6 device listings, 8 product codes, first listed Jan 4, 2013
- 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 |
|---|---|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | Class II | Immunology | Contract manufacturing | Jan 4, 2013 |
| DDG | Transferrin, Antigen, Antiserum, Control | Class II | Immunology | Contract manufacturing | Jan 4, 2013 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| JIX | Calibrator, Multi-Analyte Mixture | Class II | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| MSJ | Apolipoproteins | Class I | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Class III | Microbiology | Contract manufacturing | Dec 1, 2019 |