FDA device listing
Alinity m MPXV AMP Kit,Alinity m MPXV Application Specification File,Alinity m MPXV CTRL Kit
FDA device listing 1037720488 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity m MPXV AMP Kit,Alinity m MPXV Application Specification File,Alinity m MPXV CTRL Kit |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | QTP |
| Device names | QTP - Reagents, Monkeypox Virus Nucleic Acid. |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QTP |
| Review panels | Microbiology |
| Registered establishments | ABBOTT MOLECULAR, INC. |
| Establishment registrations | 3005248192 |
| FEI numbers | 3005248192 |
| Establishment operations | Manufacturer |
| 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