FDA device listing
Automated Nucleic Acid Extraction System - Aurora PANA X6,Automatic Nucleic Acid Extractor-GeneFlex 16,GeneFlex 32…
FDA device listing 1044445707 · Xian Tianlong Science and Technology Co., Ltd.
Key facts
| Proprietary names | Automated Nucleic Acid Extraction System - Aurora PANA X6,Automatic Nucleic Acid Extractor-GeneFlex 16,GeneFlex 32, GeneFlex 48, GeneFlex 96, GeneFlex 192,Automatic Nucleic Acid Extractor- GeneRotex 24,Automatic Nucleic Acid Extractor-GeneRotex 96, GeneRotex 48,Automatic Nucleic Acid Extractor-Libex,Automatic Nucleic Acid Extractor-Npex 192,Automatic Nucleic Acid Workstation - PANA 3200S, PANA… |
|---|---|
| Owner/operator | Xian Tianlong Science and Technology Co., Ltd. |
| Owner/operator number | 10075325 |
| Product codes | JJH |
| Device names | JJH - Clinical Sample Concentrator |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2310 |
| 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