FDA device listing
PL 92/PL 92A/PL 92B Alanine Aminotransferase Test Strip
FDA device listing 1914868001 · URIT Medical Electronic Co., Ltd
Key facts
| Proprietary names | PL 92/PL 92A/PL 92B Alanine Aminotransferase Test Strip |
|---|---|
| Owner/operator | URIT Medical Electronic Co., Ltd |
| Owner/operator number | 10055160 |
| Product codes | CKD |
| Device names | CKD - Hydrazone Colorimetry, Alt/Sgpt |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1030 |
| Review panels | Clinical Chemistry |
| Registered establishments | URIT Medical Electronic Co., Ltd. |
| Establishment registrations | 3010891909 |
| FEI numbers | 3010891909 |
| 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