Biobase
18 catalogue numbers from R1:50mL×2 R2:25mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
18catalogue 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 | Biobase Biodustry(Shandong)Co., Ltd., China |
|---|---|
| FDA product code | CKA |
| Device type | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1030 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1:50mL×2 R2:25mL×1 | In distribution | |
| R1:48mL×2 R2:12mL×2 | In distribution | |
| R1:40mL×4 R2:20mL×2 | In distribution | |
| R1:20mL×4 R2:5mL×4 | In distribution | |
| R1:64mL×6 R2:48mL×2 | In distribution | |
| R1:64mL×2 R2:16mL×2 | In distribution | |
| R1:48mL×2 R2:24mL×1 | In distribution | |
| R1:48mL×2 R2:24mL×1 | In distribution | |
| R1:80mL×1 R2:20mL×1 | In distribution | |
| R1:48mL×2 R2:12mL×2 | In distribution | |
| R1:20mL×4 R2:5mL×4 | In distribution | |
| R1:48mL×2 R2:12mL×2 | In distribution | |
| R1:48mL×2 R2:12mL×2 | In distribution | |
| R1:80mL×2 R2:20mL×2 | In distribution | |
| R1:20mL×1 R2:5mL×1 | In distribution | |
| R1:20mL×4 R2:5mL×4 | In distribution | |
| R1:100mL×1 R2:25mL×1 | In distribution | |
| R1:48mL×2 R2:12mL×2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Architect | Abbott Medical | 3 |
| 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.