FDA device listing
PCR Thermal Cycler-Genesy 96T
FDA device listing 1952300412 · Xian Tianlong Science and Technology Co., Ltd.
Key facts
| Proprietary names | PCR Thermal Cycler-Genesy 96T |
|---|---|
| Owner/operator | Xian Tianlong Science and Technology Co., Ltd. |
| Owner/operator number | 10075325 |
| Product codes | OOI |
| Device names | OOI - Real Time Nucleic Acid Amplification System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | XIAN TIANLONG SCIENCE AND TECHNOLOGY CO., LTD. |
| Establishment registrations | 3012259842 |
| FEI numbers | 3012259842 |
| Establishment operations | 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