FDA device listing
KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD,KIT COBAS 4800 HSV 1/2 CONTROLS IVD
FDA device listing 1734084746 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD,KIT COBAS 4800 HSV 1/2 CONTROLS IVD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K150617 |
| Product codes | OQO |
| Device names | OQO - Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3305 |
| 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