FDA device listing
Abbott RealTime HCV Genotype II Amplification Including Uracil-N-Glycosylase (UNG) 08L21-066, 6L87-02,Abbott RealTime…
FDA device listing 1298217069 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Abbott RealTime HCV Genotype II Amplification Including Uracil-N-Glycosylase (UNG) 08L21-066, 6L87-02,Abbott RealTime HCV Genotype II Control Kit 08L21-080,Abbott RealTime HCV Genotype m2000 combined App Spec 08L21,Abbott RealTime HCV Gentoype II Amplification Reagent Kit 08L21-090 |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P120012 |
| Product codes | OBF |
| Device names | OBF - Assay, Genotyping, Hepatitis C Virus |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3170 |
| Review panels | Microbiology |
| Registered establishments | ABBOTT MOLECULAR, INC. |
| Establishment registrations | 3005248192 |
| FEI numbers | 3005248192 |
| 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