Contract manufacturerBio-Rad Laboratories Inc. (Irvine, CA)CaliforniaClinical chemistryClass II
Bio-Rad Laboratories Inc.
Contract manufacturer ยท Irvine, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2016706 (openFDA record; or search FDA's registration database)
- FEI number
- 2016706
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- Bio-Rad Laboratories, Inc. (FDA owner/operator no. 9929003)
- Registered address
- 9500 Jeronimo Rd, Irvine, CA 92618
- Contract listings
- 1 device listings, 1 product codes, first listed May 19, 2014
- 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 |
|---|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Class II | Clinical chemistry | Contract manufacturing | May 19, 2014 |