Contract manufacturerCALBIOTECH, INC. (El Cajon, CA)CaliforniaImmunologyMicrobiologyPathologyClass IIClass I
CALBIOTECH, INC.
Contract manufacturer · El Cajon, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2090110 (openFDA record; or search FDA's registration database)
- FEI number
- 3002346973
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Calbiotech, Inc. (FDA owner/operator no. 9046880)
- Registered address
- 1935 Cordell Ct, El Cajon, CA 92020
- Contract listings
- 15 device listings, 10 product codes, first listed Nov 16, 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 |
|---|---|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | Class II | Immunology | Contract manufacturing | Sep 16, 2024 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | Class II | Microbiology | Contract manufacturing | Apr 4, 2023 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | Class II | Microbiology | Contract manufacturing | Apr 4, 2023 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | Class II | Microbiology | Contract manufacturing | Sep 16, 2024 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | Class I | Microbiology | Contract manufacturing | Sep 16, 2024 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | Class I | Microbiology | Contract manufacturing | Jun 5, 2024 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | Class II | Immunology | Contract manufacturing | Apr 4, 2023 |
| LSE | Epstein-Barr Virus, Other | Class I | Microbiology | Contract manufacturing | Apr 4, 2023 |
| MVU | Reagents, Specific, Analyte | Class I | Pathology | Contract manufacturing | Nov 17, 2006 |
| PPM | General Purpose Reagent | Class I | Pathology | Contract manufacturing | Nov 16, 2006 |