FDA device listing
cobas Influenza A/B Nucleic acid test for use on the cobas Liat system,cobas Liat system,cobas® Liat®System Software…
FDA device listing 1862878436 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas Influenza A/B Nucleic acid test for use on the cobas Liat system,cobas Liat system,cobas® Liat®System Software v3.3,Roche cobas Liat Module,SW USB Cobas Liat Core V3.3 |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K111387 |
| Product codes | OCC, OOI |
| Device names | OCC - Respiratory Virus Panel Nucleic Acid Assay System, OOI - Real Time Nucleic Acid Amplification System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3980 |
| 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
- None 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