Pointe ALT for the BS480
Pointe ALT packaged for the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Alanine Aminotransferase in serum on the BS480 Analyzer.
3manufacturers in China registered for this device type
1catalogue number
8recalls on this code
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 | Horiba Instruments Incorporated, 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 |
| Record published | 2020-05-28 |
| Record revised | 2025-10-02 (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 |
|---|---|---|
| 14-A7526-375 | 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 |
| 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 |
Showing 12 of 57. All products under Nadh Oxidation/Nad Reduction, Alt/Sgpt
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
| 2007-12-14 | Not classified | Process control | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 955 for all products. | 2008-09-15 |
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.