Contract manufacturerFujirebio Diagnostics, Inc. (Seguin, TX)TexasClinical toxicologyClinical chemistryHematologyClass II
Fujirebio Diagnostics, Inc.
Contract manufacturer ยท Seguin, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1643621 (openFDA record; or search FDA's registration database)
- FEI number
- 1643621
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Fujirebio Diagnostics, Inc. (FDA owner/operator no. 10022860)
- Registered address
- 940 Crossroads Blvd, Seguin, TX 78155
- Contract listings
- 5 device listings, 6 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 |
| KSZ | System, Test, Automated Blood Grouping And Antibody | Class II | Hematology | Contract manufacturing | May 30, 2008 |
| MKW | Cyclosporine | Class II | Clinical chemistry | Contract manufacturing | Nov 17, 2008 |
| MLM | Enzyme Immunoassay, Tracrolimus | Class II | Clinical chemistry | Contract manufacturing | Oct 17, 2007 |
| NRP | Sirolimus Test System | Class II | Clinical toxicology | Contract manufacturing | Oct 17, 2007 |