FDA device listing
Micro Albumin,Urinary Test Non-Quant., Protein,Urine Test Strip for Albumin-to-Creatinine Ratio
FDA device listing 1331769293 · Changchun Merydi Bio-Tech Co., Ltd.
Key facts
| Proprietary names | Micro Albumin,Urinary Test Non-Quant., Protein,Urine Test Strip for Albumin-to-Creatinine Ratio |
|---|---|
| Owner/operator | Changchun Merydi Bio-Tech Co., Ltd. |
| Owner/operator number | 10093200 |
| Product codes | JIR |
| Device names | JIR - Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1645 |
| Review panels | Clinical Chemistry |
| 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