FDA device listing
TaqPath COVID-19 Fast PCR Combo Kit 2.0,TaqPath COVID-19, FluA, FluB Combo Kit,TaqPath COVID-19 RNase P Combo Kit 2.0
FDA device listing 1723986161 · Life Technologies Corporation
Key facts
| Proprietary names | TaqPath COVID-19 Fast PCR Combo Kit 2.0,TaqPath COVID-19, FluA, FluB Combo Kit,TaqPath COVID-19 RNase P Combo Kit 2.0 |
|---|---|
| Owner/operator | Life Technologies Corporation |
| Owner/operator number | 9915045 |
| Product codes | QJR |
| Device names | QJR - Reagents, 2019-Novel Coronavirus Nucleic Acid |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QJR |
| Review panels | Microbiology |
| Registered establishments | Life Technologies Corporation, LIFE TECHNOLOGIES CORPORATION |
| Establishment registrations | 3003335080, 3009207631, 3009976420, 3011104381 |
| FEI numbers | 3003335080, 3009207631, 3009976420, 3011104381 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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