FDA device listing
cobas 6800 System,cobas 8800 System,cobas® HBV,cobas HBV assay specific analysis package (ASAP) software,cobas…
FDA device listing 1359806188 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas 6800 System,cobas 8800 System,cobas® HBV,cobas HBV assay specific analysis package (ASAP) software,cobas HBV/HCV/HIV-1 Control Kit (HPC and LPC) in cassettes,cobas HBV in cassettes,cobas NHP Negative Control Kit in cassettes,KIT COBAS 58/68/8800 HBV 192T IVD,Specimen preparation reagents (cobas omni Reagents),SW cobas HBV ASAP Software |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | P150014 |
| Product codes | MKT |
| Device names | MKT - Hepatitis Viral B Dna Detection |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3174 |
| 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
- 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