Contract manufacturerSekisui Diagnostics, LLC (San Diego, CA)CaliforniaMicrobiologyClinical chemistryImmunologyClass IClass II
Sekisui Diagnostics, LLC
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2030538 (openFDA record; or search FDA's registration database)
- FEI number
- 1000520007
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Sekisui Diagnostics, LLC (FDA owner/operator no. 10035388)
- Registered address
- 6659 Top Gun St, San Diego, CA 92121
- Contract listings
- 6 device listings, 5 product codes, first listed Feb 25, 2011
- 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 |
|---|---|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | Class I | Microbiology | Contract manufacturing | Feb 25, 2011 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Class I | Microbiology | Contract manufacturing | Feb 25, 2011 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Class II | Clinical chemistry | Contract manufacturing | Feb 25, 2011 |
| KTN | System, Test, Infectious Mononucleosis | Class II | Immunology | Contract manufacturing | Feb 25, 2011 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Class II | Microbiology | Contract manufacturing | Apr 8, 2020 |