FDA device listing
cobas Influenza A/B Quality Control Kit for use on the cobas Liat System,cobas Influenza A/B & RSV Nucleic Acid Test for…
FDA device listing 1504629507 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas Influenza A/B Quality Control Kit for use on the cobas Liat System,cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System,cobas Influenza A/B & RSV Quality Control Kit,cobas Liat Influenze A/B & RSV,cobas Liat System,KIT COBAS LIAT FLU A/B & RSV US-IVD,KIT COBAS LIAT INFLUENZA A/B & RSV CTL,SW USB COBAS LIAT INFLUENZA RSV |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K153544 |
| Product codes | OCC, OOI, OZE |
| Device names | OCC - Respiratory Virus Panel Nucleic Acid Assay System, OOI - Real Time Nucleic Acid Amplification System, OZE - Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| 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