Data / Medical devices / United States / COPAN Diagnostics, Inc.
COPAN Diagnostics, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
COPAN Diagnostics, Inc. is registered with the FDA (registration 3017063217) in Carlsbad, CA, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017063217
- Address
- 2728 Loker Ave. W, Carlsbad, CA, United States, 92010
- Owner or operator
- COPAN ITALIA Spa (9016900)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 27, 1995
- Registered through
- 2026
- Brand names listed
- ACT Transfer Pipettes, AeroMed Transfer Pipettes, BC+, BD BBL UVT, BD Universal Viral Transport, Buccal Swab, CLASSIQSwab, Cepheid Xpert Xpress Nasopharyngeal Collection Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Contract manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 2004 | K042970 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM | JSM | Substantially Equivalent | Copan Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Specimen Collection
- All makers of Culture Media, Non-Propagating Transport
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Container, Specimen Mailer And Storage, Sterile
- All makers of Micro Pipette
- All makers of General Purpose Reagent
Updated December 7, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.