FDA device listing
Alinity m Diluent Solution,Alinity m Lysis Solution
FDA device listing 1458052213 · RPI BIOSOLUTIONS
Key facts
| Proprietary names | Alinity m Diluent Solution,Alinity m Lysis Solution |
|---|---|
| Owner/operator | RPI BIOSOLUTIONS |
| Owner/operator number | 10086908 |
| Product codes | LSL, MKZ, OUY, QEP |
| Device names | LSL - Dna-Reagents, Neisseria, MKZ - Dna Probe, Nucleic Acid Amplification, Chlamydia, 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) | 866.3120, 866.3390, 866.3393, 866.3860 |
| Review panels | Immunology, Microbiology |
| Registered establishments | RPI BIOSOLUTIONS |
| Establishment registrations | 3025663244 |
| FEI numbers | 3025663244 |
| Establishment operations | Contract 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