FDA device listing
Alatoxin B1 Quantitative Test (Time-Resolved Fluoroimmunoassay);,B1 Vomitoxin QuantitativeTest (Time-Res…
FDA device listing 1214937889 · Jilin Hongyi Bio-Tech Co., Ltd.
Key facts
| Proprietary names | Alatoxin B1 Quantitative Test (Time-Resolved Fluoroimmunoassay);,B1 Vomitoxin QuantitativeTest (Time-Res Olvedfuoroimmunoassay); Oil Test Strip; Water Test Strips,,Reagent Strips For Water; Zearalenone Quantitative Test (Time-ResolvedfluoroimmunoasSay) |
|---|---|
| Owner/operator | Jilin Hongyi Bio-Tech Co., Ltd. |
| Owner/operator number | 10094749 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | JILIN HONGYI BIO-TECH CO., LTD. |
| Establishment registrations | 3043127699 |
| FEI numbers | 3043127699 |
| Establishment operations | Foreign Exporter, 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