FDA device listing
cobas liat Bordetella panel control kit,cobas liat Bordetella panel nucleic acid test,KIT COBAS LIAT BORDETELLA PANEL…
FDA device listing 1774110026 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas liat Bordetella panel control kit,cobas liat Bordetella panel nucleic acid test,KIT COBAS LIAT BORDETELLA PANEL CTL IVD,KIT COBAS LIAT BORDETELLA PANEL IVD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K243753 |
| Product codes | OOI, OZZ |
| Device names | OOI - Real Time Nucleic Acid Amplification System, OZZ - Bordetella Pertussis Dna Assay System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3980 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | ROCHE MOLECULAR SYSTEMS, INC. |
| Establishment registrations | 2243471, 3004141078 |
| FEI numbers | 2243471, 3004141078 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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