Contract manufacturerCLINIQA CORPORATION (San Marcos, CA)CaliforniaClinical chemistryHematologyImmunologyClass IIClass I
CLINIQA CORPORATION
Contract manufacturer · San Marcos, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2085064 (openFDA record; or search FDA's registration database)
- FEI number
- 1000135102
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- CLINIQA CORPORATION (FDA owner/operator no. 2083131)
- Registered address
- 495 Enterprise Street, San Marcos, CA 92078
- Contract listings
- 22 device listings, 15 product codes, first listed Jun 13, 2006
- 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 |
|---|---|---|---|---|---|
| CDN | Urease, Photometric, Urea Nitrogen | Class II | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| CEM | Electrode, Ion Specific, Potassium | Class II | Clinical chemistry | Contract manufacturing | Jul 20, 2010 |
| CGZ | Electrode, Ion-Specific, Chloride | Class II | Clinical chemistry | Contract manufacturing | Jul 20, 2010 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | Class I | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| GGN | Plasma, Coagulation Control | Class II | Hematology | Contract manufacturing | Aug 9, 2023 |
| GJS | Test, Time, Prothrombin | Class II | Hematology | Contract manufacturing | Feb 23, 2024 |
| JGS | Electrode, Ion Specific, Sodium | Class II | Clinical chemistry | Contract manufacturing | Jul 20, 2010 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Dec 17, 2013 |
| JIX | Calibrator, Multi-Analyte Mixture | Class II | Clinical chemistry | Contract manufacturing | Sep 9, 2024 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Jul 20, 2010 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Nov 9, 2009 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Jun 13, 2006 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | Clinical chemistry | Contract manufacturing | Nov 9, 2009 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | Class I | Clinical chemistry | Contract manufacturing | Jan 4, 2013 |
| QAT | Brain Trauma Assessment Test | Class II | Immunology | Contract manufacturing | May 29, 2024 |