FDA device listing
cobas Cdiff Nucleic acid test for use on the cobas Liat System,cobas Cdiff Positive and Negative Control Kit for use on…
FDA device listing 1040213773 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas Cdiff Nucleic acid test for use on the cobas Liat System,cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System,KIT COBAS LIAT CDIFF Controls,KIT COBAS LIAT CDIFF IVD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K171770 |
| Product codes | OOI, OZN |
| Device names | OOI - Real Time Nucleic Acid Amplification System, OZN - C. Difficile Toxin Gene Amplification Assay |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3130 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, ROCHE DIAGNOSTICS INTERNATIONAL LTD., ROCHE MOLECULAR SYSTEMS, INC. |
| Establishment registrations | 2243471, 9610126, 3003795116, 3004141078 |
| FEI numbers | 2243471, 3002806559, 3003795116, 3004141078 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| 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