Contract manufacturerHARDY DIAGNOSTICS (Orcutt, CA)CaliforniaMicrobiologyClass IClass II
HARDY DIAGNOSTICS
Contract manufacturer · Orcutt, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2022807 (openFDA record; or search FDA's registration database)
- FEI number
- 2022807
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- HARDY DIAGNOSTICS (FDA owner/operator no. 2022807)
- Registered address
- 1430 WEST MCCOY LN., Orcutt, CA 93455
- Contract listings
- 2 device listings, 3 product codes, first listed Jan 15, 2013
- 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 |
|---|---|---|---|---|---|
| JTA | Monitor, Microbial Growth | Class I | Microbiology | Contract manufacturing | Jan 15, 2013 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class II | Microbiology | Contract manufacturing | Nov 6, 2024 |
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | Class II | Microbiology | Contract manufacturing | Nov 6, 2024 |