AU
AST
2manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | CIT |
| Device type | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1100 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K925155 |
| Record published | 2016-09-24 |
| Record revised | 2023-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSR6609 | In distribution | |
| OSR6509 | In distribution | |
| OSR6209 | In distribution | |
| OSR6109 | 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 |
| 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 |
| Aspartate aminotransferase acc to Ifcc withwithout pyridoxal phosphate activat | Roche Diagnostics Gmbh | 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.