Architect
Activated Alanine Aminotransferase
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Abbott Medical, United States |
|---|---|
| FDA product code | CKA |
| Device type | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1030 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-02-12 |
| Record revised | 2020-06-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| 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 |
|---|---|---|
| 8L92-42 | In distribution | |
| 7D56-22 | In distribution | |
| 8L92-22 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 18 |
| Alanine Aminotransferase (ALT) | Randox Laboratories Limited | 10 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Carolina Liquid Chemistries Corp.® Alanine Aminotransferase Reagent KIT ST240 | Carolina Liquid Chemistries | 4 |
| Synchron | Beckman Coulter, Inc. | 4 |
| Architect | Abbott Ireland | 4 |
| Alinity | Abbott Ireland | 3 |
| Pointe Scientific ALT (Sgpt) Liquid | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| Alanine Aminotransferase acc. to Ifcc without pyridoxal phosphate activation | Roche Diagnostics Gmbh | 2 |
Showing 12 of 57. All products under Nadh Oxidation/Nad Reduction, Alt/Sgpt
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.