FDA device listing
BC+,Copan FLOQSwabs with Empty Tube,Dry Swab Tube,Plain Dry Screw Cap Tube,Sterile Dry Tube,UriFree
FDA device listing 1418713663 · COPAN ITALIA Spa
Key facts
| Proprietary names | BC+,Copan FLOQSwabs with Empty Tube,Dry Swab Tube,Plain Dry Screw Cap Tube,Sterile Dry Tube,UriFree |
|---|---|
| Owner/operator | COPAN ITALIA Spa |
| Owner/operator number | 9016900 |
| Product codes | KDT |
| Device names | KDT - Container, Specimen Mailer And Storage, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | COPAN Diagnostics, Inc., COPAN DIAGNOSTICS, INC., COPAN ITALIA |
| Establishment registrations | 2436875, 3002444944, 3017063217 |
| FEI numbers | 1000521444, 3002444944, 3017063217 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database