FDA device listing
BD FCT,BD FecalSwab,Copan FecalSwab
FDA device listing 1659177489 · COPAN ITALIA Spa
Key facts
| Proprietary names | BD FCT,BD FecalSwab,Copan FecalSwab |
|---|---|
| Owner/operator | COPAN ITALIA Spa |
| Owner/operator number | 9016900 |
| Premarket submissions | K142094 |
| Product codes | JSM, LIO |
| Device names | JSM - Culture Media, Non-Propagating Transport, LIO - Device, Specimen Collection |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2390, 866.2900 |
| Review panels | Microbiology |
| Registered establishments | COPAN DIAGNOSTICS, INC., Copan Industries, Inc., COPAN ITALIA |
| Establishment registrations | 2436875, 3002444944, 3015441043 |
| FEI numbers | 1000521444, 3002444944, 3015441043 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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