FDA device listing
Alinity m BKV Amplification Reagent Kit,Alinity m BKV Application Specification File,Alinity m BKV Calibrator…
FDA device listing 1751965150 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity m BKV Amplification Reagent Kit,Alinity m BKV Application Specification File,Alinity m BKV Calibrator Kit,Alinity m BKV Control Kit |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | QMI |
| Device names | QMI - Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3183 |
| Review panels | Microbiology |
| Registered establishments | Abbott Molecular Distribution Center, ABBOTT MOLECULAR, INC. |
| Establishment registrations | 3005248192, 3019837962 |
| FEI numbers | 3005248192, 3019837962 |
| 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