Contract manufacturerADVIN BIOTECH, INC. (San Diego, CA)CaliforniaClinical toxicologyClinical chemistryMicrobiologyClass IIUnclassifiedClass INot classified
ADVIN BIOTECH, INC.
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010934853 (openFDA record; or search FDA's registration database)
- FEI number
- 3010934853
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Advin Biotech Inc (FDA owner/operator no. 10046939)
- Registered address
- 10140 Mesa Rim Rd., Unit 1, San Diego, CA 92121
- Contract listings
- 9 device listings, 14 product codes, first listed Jan 11, 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 |
|---|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class II | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| DJC | Thin Layer Chromatography, Methamphetamine | Class II | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| DJR | Enzyme Immunoassay, Methadone | Class II | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| DKZ | Enzyme Immunoassay, Amphetamine | Class II | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unclassified | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Class II | Clinical toxicology | Contract manufacturing | May 26, 2022 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | Class I | Clinical toxicology | Contract manufacturing | Aug 27, 2025 |
| OHQ | Multi-Analyte Controls Unassayed | Class I | Clinical chemistry | Contract manufacturing | Aug 12, 2020 |
| PUZ | Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class II | Clinical toxicology | Contract manufacturing | Aug 27, 2025 |
| PVE | Test, Methadone, Employment And Insurance Testing, Exempt | Class II | Clinical toxicology | Contract manufacturing | Aug 27, 2025 |
| PVF | Test, Methaqualone, Employment And Insurance Testing, Exempt | Class II | Clinical toxicology | Contract manufacturing | Mar 21, 2018 |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class II | Clinical toxicology | Contract manufacturing | Jan 11, 2018 |
| QKO | Reagent, Coronavirus Serological | Not classified | Microbiology | Contract manufacturing | Jun 16, 2020 |