Contract manufacturerCOPAN DIAGNOSTICS, INC. (Murrieta, CA)CaliforniaMicrobiologyClass IClass II
COPAN DIAGNOSTICS, INC.
Contract manufacturer · Murrieta, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2436875 (openFDA record; or search FDA's registration database)
- FEI number
- 1000521444
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- COPAN ITALIA Spa (FDA owner/operator no. 9016900)
- Registered address
- 26055, 26083 & 26087 Jefferson Avenue, Murrieta, CA 92562
- Contract listings
- 5 device listings, 6 product codes, first listed Jan 8, 2008
- 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 |
|---|---|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | Class I | Microbiology | Contract manufacturing | Jan 8, 2008 |
| LIO | Device, Specimen Collection | Class I | Microbiology | Contract manufacturing | Jun 27, 2018 |
| LSL | Dna-Reagents, Neisseria | Class II | Microbiology | Contract manufacturing | May 28, 2019 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | Class I | Microbiology | Contract manufacturing | May 28, 2019 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | Class II | Microbiology | Contract manufacturing | May 28, 2019 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | Class II | Microbiology | Contract manufacturing | May 28, 2019 |