FDA device listing
Alinity m Ethanol Solution,Alinity m STI Amplification Reagent Kit,Alinity m STI Amplification Reagent Kit…
FDA device listing 1478731904 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity m Ethanol Solution,Alinity m STI Amplification Reagent Kit,Alinity m STI Amplification Reagent Kit (09N17-092),Alinity m STI Application Specification File,Alinity m STI Control Kit,simpli-COLLECT Swab Collection Kit,simpli-COLLECT Urine Collection Kit |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | QEP |
| Device names | QEP - Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3393 |
| Review panels | Microbiology |
| Registered establishments | ABBOTT MOLECULAR, INC. |
| Establishment registrations | 3005248192 |
| FEI numbers | 3005248192 |
| 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