Contract manufacturerTRUE DIAGNOSTICS, INC. (Carlsbad, CA)CaliforniaGeneral hospitalClinical chemistryMicrobiologyClass IIClass INot classified
TRUE DIAGNOSTICS, INC.
Contract manufacturer · Carlsbad, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3027500452 (openFDA record; or search FDA's registration database)
- FEI number
- 3027500452
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Contract manufacturer
- Owner or operator
- True Diagnostics, Inc. (FDA owner/operator no. 10058307)
- Registered address
- 5919 Farnsworth Ct, Carlsbad, CA 92008
- Contract listings
- 3 device listings, 3 product codes, first listed Nov 2, 2023
- 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 |
|---|---|---|---|---|---|
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Apr 28, 2025 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Class I | Clinical chemistry | Contract manufacturing | Aug 31, 2024 |
| QKP | Coronavirus Antigen Detection Test System. | Not classified | Microbiology | Contract manufacturing | Nov 2, 2023 |