FDA device listing
INFORM HPV II Family 6 Probe,INFORM HPV III Family 16 Probe (B),KIT cobas 4800 HPV AMP/DET 240T CE-IVD,KIT cobas 4800…
FDA device listing 1848037266 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | INFORM HPV II Family 6 Probe,INFORM HPV III Family 16 Probe (B),KIT cobas 4800 HPV AMP/DET 240T CE-IVD,KIT cobas 4800 HPV AMP/DET 960T CE-IVD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | MAQ |
| Device names | MAQ - Kit, Dna Detection, Human Papillomavirus |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MAQ |
| Review panels | Microbiology |
| Registered establishments | ROCHE MOLECULAR SYSTEMS, INC., VENTANA MEDICAL SYSTEMS, INC. |
| Establishment registrations | 2028492, 2243471 |
| FEI numbers | 2243471, 1000125183 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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