Contract manufacturerRESEARCHDX,INC. (Irvine, CA)CaliforniaPathologyClinical chemistryClass INot classified
RESEARCHDX,INC.
Contract manufacturer · Irvine, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3012177275 (openFDA record; or search FDA's registration database)
- FEI number
- 3012177275
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- ResearchDx,Inc. (FDA owner/operator no. 10075876)
- Registered address
- 5 Mason, Irvine, CA 92618
- Contract listings
- 3 device listings, 3 product codes, first listed Jul 6, 2020
- 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 |
|---|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Class I | Pathology | Contract manufacturing | Apr 15, 2022 |
| PDA | Investigational Use Only - Clinical Chemistry | Not classified | Clinical chemistry | Contract manufacturing | Jul 6, 2020 |
| PDD | Investigational Use Only - Pathology | Not classified | Pathology | Contract manufacturing | Jul 6, 2020 |