Contract manufacturerAdvanced Cell Diagnostics, Inc. (Newark, CA)CaliforniaPathologyClass I
Advanced Cell Diagnostics, Inc.
Contract manufacturer ยท Newark, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009161685 (openFDA record; or search FDA's registration database)
- FEI number
- 3009161685
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Advanced Cell Diagnostics (FDA owner/operator no. 10051491)
- Registered address
- 7707 Gateway Blvd, Suite 200, Newark, CA 94560
- Contract listings
- 2 device listings, 2 product codes, first listed Mar 25, 2016
- 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 |
|---|
| MVU | Reagents, Specific, Analyte | Class I | Pathology | Contract manufacturing | Jul 22, 2016 |
| PPM | General Purpose Reagent | Class I | Pathology | Contract manufacturing | Mar 25, 2016 |