Contract manufacturerFujirebio Diagnostics, Inc. (Malvern, PA)PennsylvaniaClinical toxicologyClinical chemistryImmunologyObstetrics and gynecologyMicrobiologyClass IIClass INot classified
Fujirebio Diagnostics, Inc.
Contract manufacturer ยท Malvern, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2521625 (openFDA record; or search FDA's registration database)
- FEI number
- 2521625
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- Fujirebio Diagnostics, Inc. (FDA owner/operator no. 10022860)
- Registered address
- 201 Great Valley Parkway, Malvern, PA 19355
- Contract listings
- 19 device listings, 15 product codes, first listed Oct 17, 2007
- 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 |
|---|---|---|---|---|---|
| DLJ | Calibrators, Drug Specific | Class II | Clinical toxicology | Contract manufacturing | Nov 17, 2008 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Oct 17, 2007 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Oct 17, 2007 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | Class II | Immunology | Contract manufacturing | Oct 17, 2007 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | Class II | Immunology | Contract manufacturing | Oct 17, 2007 |
| MKW | Cyclosporine | Class II | Clinical chemistry | Contract manufacturing | Nov 17, 2008 |
| MLM | Enzyme Immunoassay, Tracrolimus | Class II | Clinical chemistry | Contract manufacturing | Oct 17, 2007 |
| MOI | System, Test, Immunological, Antigen, Tumor | Class II | Immunology | Contract manufacturing | Oct 17, 2007 |
| NBC | Test, Natriuretic Peptide | Class II | Clinical chemistry | Contract manufacturing | Oct 17, 2007 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | Class II | Immunology | Contract manufacturing | Oct 17, 2007 |
| NRP | Sirolimus Test System | Class II | Clinical toxicology | Contract manufacturing | Oct 17, 2007 |
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | Class II | Immunology | Contract manufacturing | Mar 23, 2010 |
| ONX | Ovarian Adnexal Mass Assessment Score Test System | Class II | Obstetrics and gynecology | Contract manufacturing | Jul 5, 2016 |
| OSX | Galectin-3 In Vitro Diagnostic Assay | Class II | Clinical chemistry | Contract manufacturing | Dec 30, 2014 |
| QKO | Reagent, Coronavirus Serological | Not classified | Microbiology | Contract manufacturing | Apr 22, 2020 |