FDA device listing
Alinity m Bottle for Ethanol Use,Alinity m Diluent Solution,Alinity m Ethanol Solution,Alinity m Lysis Solution,Alinity…
FDA device listing 1200101773 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity m Bottle for Ethanol Use,Alinity m Diluent Solution,Alinity m Ethanol Solution,Alinity m Lysis Solution,Alinity m Multi-Collect Specimen Collection Kit,Alinity m Sample Prep Kit 1,Alinity m STI Amplification Reagent Kit,Alinity m STI Application Specification File,Alinity m STI Control Kit,Alinity m System,Alinity m Vapor Barrier Solution |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K202977 |
| Product codes | LSL, MKZ, OOI, OUY, QEP |
| Device names | LSL - Dna-Reagents, Neisseria, MKZ - Dna Probe, Nucleic Acid Amplification, Chlamydia, OOI - Real Time Nucleic Acid Amplification System, OUY - Trichomonas Vaginalis Nucleic Acid Amplification Test System, QEP - Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3120, 866.3390, 866.3393, 866.3860 |
| Review panels | Clinical Chemistry, Immunology, 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