ACE
AST Reagent
2manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
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 | Alfa Wassermann, United States |
|---|---|
| FDA product code | CIT |
| Device type | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1100 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K113382 |
| Record published | 2020-07-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA1053 | In distribution | |
| RX1047 | In distribution | |
| RX1053 | In distribution | |
| SA1047 | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alfa Wassermann | 510(k) number | 2014-03-05 | Class II | Process control | Extremely low absorbance readings. | SA1047 lot F3609: 146; RX1047 lot F3610: 53 | 2015-08-13 |
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.