Contract manufacturerSCANTIBODIES LABORATORY, INC. (Santee, CA)CaliforniaMicrobiologyClass IClass IINot classified
SCANTIBODIES LABORATORY, INC.
Contract manufacturer · Santee, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2020808 (openFDA record; or search FDA's registration database)
- FEI number
- 2020808
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- Scantibodies Laboratory Inc. (FDA owner/operator no. 2020808)
- Registered address
- 9336 ABRAHAM WAY, Santee, CA 92071
- Contract listings
- 4 device listings, 4 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 |
|---|---|---|---|---|---|
| LQP | Campylobacter Spp. | Class I | Microbiology | Contract manufacturing | Feb 2, 2022 |
| LSR | Reagent, Borrelia Serological Reagent | Class II | Microbiology | Contract manufacturing | Jan 11, 2021 |
| QKP | Coronavirus Antigen Detection Test System. | Not classified | Microbiology | Contract manufacturing | Nov 18, 2020 |
| QMN | Covid-19 Multi-Analyte Antigen Device | Not classified | Microbiology | Contract manufacturing | Nov 20, 2020 |