Contract manufacturerORTHO-CLINICAL DIAGNOSTICS, INC. (Raritan, NJ)New JerseyHematologyClass II
ORTHO-CLINICAL DIAGNOSTICS, INC.
Contract manufacturer · Raritan, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2250051 (openFDA record; or search FDA's registration database)
- FEI number
- 2250051
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- QuidelOrtho Corporation (FDA owner/operator no. 2024674)
- Registered address
- 1001 US Highway 202, Raritan, NJ 08869
- Contract listings
- 2 device listings, 1 product codes, first listed Dec 9, 2022
- 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 |
|---|---|---|---|---|---|
| KSG | Media, Potentiating For In Vitro Diagnostic Use | Class II | Hematology | Contract manufacturing | Dec 9, 2022 |