Contract manufacturerAlere San Diego, Inc. (San Diego, CA)CaliforniaClinical chemistryHematologyClass IIClass I
Alere San Diego, Inc.
Contract manufacturer · San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2027969 (openFDA record; or search FDA's registration database)
- FEI number
- 1000125596
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- ABBOTT LABORATORIES (FDA owner/operator no. 1415939)
- Registered address
- 9942 Mesa Rim Road, 9942 Mesa Rim Road, San Diego, CA 92121
- Contract listings
- 2 device listings, 4 product codes, first listed Apr 6, 2018
- 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 |
|---|---|---|---|---|---|
| JFY | Enzymatic Method, Creatinine | Class II | Clinical chemistry | Contract manufacturing | Apr 6, 2018 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | Class I | Clinical chemistry | Contract manufacturing | Apr 6, 2018 |
| LCP | Assay, Glycosylated Hemoglobin | Class II | Hematology | Contract manufacturing | Apr 6, 2018 |
| PDJ | Hemoglobin A1c Test System | Class II | Clinical chemistry | Contract manufacturing | Mar 18, 2019 |