FDA device listing
cobas Liat system,KIT COBAS LIAT STREP A 20 PACK W/PIPETT,KIT COBAS LIAT STREP A CTL
FDA device listing 1891892177 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas Liat system,KIT COBAS LIAT STREP A 20 PACK W/PIPETT,KIT COBAS LIAT STREP A CTL |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K141338 |
| Product codes | PGX |
| Device names | PGX - Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.2680 |
| Review panels | 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