FDA device listing
Buccal Swab,CLASSIQSwab,Cotton Fiber Swab, Sterile,FLOQBrush,FLOQSwab,Foam Swab, Sterile,NuFoam Swab,Nylon Fiber Swab…
FDA device listing 1302660833 · COPAN ITALIA Spa
Key facts
| Proprietary names | Buccal Swab,CLASSIQSwab,Cotton Fiber Swab, Sterile,FLOQBrush,FLOQSwab,Foam Swab, Sterile,NuFoam Swab,Nylon Fiber Swab, Sterile,Polyester Fiber Swab, Sterile,Rayon Fiber Swab, Sterile |
|---|---|
| Owner/operator | COPAN ITALIA Spa |
| Owner/operator number | 9016900 |
| Product codes | KXG |
| Device names | KXG - Applicator, Absorbent Tipped, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6025 |
| Review panels | General Hospital |
| Registered establishments | COPAN Diagnostics, Inc., COPAN DIAGNOSTICS, INC., Copan Industries, Inc., COPAN ITALIA |
| Establishment registrations | 2436875, 3002444944, 3015441043, 3017063217 |
| FEI numbers | 1000521444, 3002444944, 3015441043, 3017063217 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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