Pointe Scientfic Inc.
ALT Reagent Set for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 5 x 100ml, 2 x 55ml
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 | 2016-08-31 |
| Record revised | 2025-10-02 (version 3) |
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 |
|---|---|---|
| HA926-610 | 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.