Contract manufacturerHardy Diagnostics (Springboro, OH)OhioMicrobiologyClass II
Hardy Diagnostics
Contract manufacturer · Springboro, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009547954 (openFDA record; or search FDA's registration database)
- FEI number
- 3009547954
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Remanufacturer; Repackager or relabeler
- Owner or operator
- HARDY DIAGNOSTICS (FDA owner/operator no. 2022807)
- Registered address
- 429 S Pioneer Blvd, Springboro, OH 45066
- Contract listings
- 1 device listings, 1 product codes, first listed Jan 10, 2022
- 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 |
|---|---|---|---|---|---|
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | Class II | Microbiology | Contract manufacturing | Jan 10, 2022 |