Alanine Aminotransferase Test Strip
3 catalogue numbers from PL 92B,25 strips/vial ×4/box, listed by Urit Medical Electronic Co., Ltd., China, under Hydrazone Colorimetry, Alt/Sgpt. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Hebei (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Jiangsu Prospect Healthcare Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 13 |
Record
| Listed by | Urit Medical Electronic Co., Ltd., China |
|---|---|
| FDA product code | CKD |
| Device type | Hydrazone Colorimetry, Alt/Sgpt |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1030 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PL 92B,25 strips/vial ×4/box | 100 | In distribution | |
| PL 92A,25 strips/vial ×4/box | 100 | In distribution | |
| PL 92,25 strips/vial ×4/box | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics ALT (Sgpt) Reagent Set (Colorimetric, Endpoint Method) | Teco Diagnostics | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.