Pointe Scientific, Inc.
Lactate Dehydrogenase Reagent, for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 4 x 100mL,…
Lactate Dehydrogenase Reagent, for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 4 x 100mL, 8 x 21mL
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | CFJ |
| Device type | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1440 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K973589 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 5) |
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 |
|---|---|---|
| HL956-568 | In distribution | |
| 13-L7572-R1-120 | In distribution | |
| L7572-150 | In distribution | |
| L7596-STD | In distribution | |
| 13-L7572-R2-30 | In distribution | |
| 13-L7572-R1-500 | In distribution | |
| 13-L7572-R2-125 | In distribution | |
| L7596-50 | In distribution | |
| L7572-625 | In distribution | |
| L7572-450 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| JAS Diagnostics | Drew Scientific, Ltd. | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Synchron | Beckman Coulter, Inc. | 4 |
| Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | Teco Diagnostics | 3 |
| Lactate dehydrogenase liquid acc to Ifcc | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 2 |
| LDH L-P | Randox Laboratories Limited | 2 |
| Lactate Dehydrogenase acc. to Ifcc ver.2 | Roche Diagnostics Gmbh | 2 |
| LDH P-L | Randox Laboratories Limited | 2 |
| Architect | Abbott Medical | 2 |
| AU | Beckman Coulter, Inc. | 2 |
Showing 12 of 60. All products under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Horiba Instruments Incorporated | 510(k) number | 2011-07-08 | Class II | Nonconforming Material/Component | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. | 716.146L total | 2017-06-02 |
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.