FDA device listing
Alinity m Bottle for Ethanol Use,Alinity m Diluent Solution,Alinity m Ethanol Solution,Alinity m HR HPV AMP Kit,Alinity…
FDA device listing 1111492234 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity m Bottle for Ethanol Use,Alinity m Diluent Solution,Alinity m Ethanol Solution,Alinity m HR HPV AMP Kit,Alinity m HR HPV Application Specification File,Alinity m HR HPV CTRL Kit,Alinity m Lysis Solution,Alinity m Sample Prep Kit 1,Alinity m Vapor Barrier Solution,simpli-COLLECT HPV Collection Kit (09R16-001) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P230003 |
| 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 | Abbott Molecular Distribution Center, ABBOTT MOLECULAR, INC. |
| Establishment registrations | 3005248192, 3019837962 |
| FEI numbers | 3005248192, 3019837962 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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