FDA device listing
aflatoxin (colloidal gold),Free Radical test; Lead test (colloidal gold),Lead Test Swab,Test For The Concentration of…
FDA device listing 1559099996 · Changchun Merydi Bio-Tech Co., Ltd.
Key facts
| Proprietary names | aflatoxin (colloidal gold),Free Radical test; Lead test (colloidal gold),Lead Test Swab,Test For The Concentration of Ortho-phthalaldehyde test,Urine Magnesium test,Urine Salinity test,Urine Zinc Test,VC |
|---|---|
| Owner/operator | Changchun Merydi Bio-Tech Co., Ltd. |
| Owner/operator number | 10093200 |
| Product codes | JXA |
| Device names | JXA - Kit, Screening, Urine |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2660 |
| Review panels | Microbiology |
| Registered establishments | CHANGCHUN MERYDI BIO-TECH CO., LTD. |
| Establishment registrations | 3038206980 |
| FEI numbers | 3038206980 |
| 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