FDA device listing
COBAS AmpliPrep/COBAS TaqMan CMV Test
FDA device listing 1044053797 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | COBAS AmpliPrep/COBAS TaqMan CMV Test |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | P110037 |
| Product codes | PAB |
| Device names | PAB - Cytomegalovirus (Cmv) Dna Quantitative Assay |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3180 |
| Review panels | 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
- 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