Contract manufacturerSCANTIBODIES LABORATORY INC. (San Diego, CA)CaliforniaMicrobiologyGeneral hospitalPathologyClass IClass IINot classified
SCANTIBODIES LABORATORY INC.
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3026664926 (openFDA record; or search FDA's registration database)
- FEI number
- 3026664926
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Scantibodies Laboratory Inc. (FDA owner/operator no. 2020808)
- Registered address
- 8005 Saint Andrews Ave, San Diego, CA 92154
- Contract listings
- 9 device listings, 9 product codes, first listed Nov 18, 2020
- 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 |
|---|---|---|---|---|---|
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Class I | Microbiology | Contract manufacturing | Jan 19, 2023 |
| KXG | Applicator, Absorbent Tipped, Sterile | Class I | General hospital | Contract manufacturing | Jan 19, 2023 |
| LLH | Reagents, Clostridium Difficile Toxin | Class I | Microbiology | Contract manufacturing | Dec 10, 2021 |
| LQP | Campylobacter Spp. | Class I | Microbiology | Contract manufacturing | Feb 2, 2022 |
| NNI | Container, Specimen, Non-Sterile | Class I | Pathology | Contract manufacturing | Jan 19, 2023 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Class II | Microbiology | Contract manufacturing | Jan 3, 2022 |
| QKO | Reagent, Coronavirus Serological | Not classified | Microbiology | Contract manufacturing | Dec 6, 2021 |
| QKP | Coronavirus Antigen Detection Test System. | Not classified | Microbiology | Contract manufacturing | Nov 18, 2020 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | Class II | Microbiology | Contract manufacturing | Jul 13, 2023 |