Carolina Liquid Chemistries Corp.® Alanine Aminotransferase Reagent KIT ST240
Alanine Aminotransferase (ALT) (GPT) Reagent
3manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
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 | Carolina Liquid Chemistries, United States |
|---|---|
| FDA product code | CKA |
| Device type | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-19 |
| Record revised | 2023-08-14 (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 |
| Sizes | Total volume 5 to 63 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST240 | Kit contains 4 R1 bottles and 4 R2 bottles | In distribution |
| BL240 | Kit contains 3 R1 bottles and 3 R2 bottles | In distribution |
| DT240 | Kit contains 4 R1 bottles and 4 R2 bottles | In distribution |
| CC240 | Total Volume 10 ml | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971323 | 1997-04-21 |
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.