IDG/Sanzay
For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and monitoring of therapy and relapses.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | IDG/Sanzay Corporation |
|---|---|
| FDA product code | CIT |
| Device type | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1100 |
| 510(k) | K981650 |
| Record published | 2024-01-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 50 to 500 ml; total volume 1 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Total Volume 50 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 19 |
| AST | Randox Laboratories Limited | 10 |
| JAS Diagnostics | Drew Scientific, Ltd. | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 5 |
| AU | Beckman Coulter, Inc. | 4 |
| Architect | Abbott Ireland | 4 |
| Synchron | Beckman Coulter, Inc. | 4 |
| ACE | Alfa Wassermann | 4 |
| Architect | Abbott Medical | 3 |
| Alinity | Abbott Ireland | 3 |
| Architect | Abbott Laboratories | 3 |
Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot
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.