LDH Reagent Set
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum…
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.
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 | Clinical Diagnostic Solutions, Inc., United States |
|---|---|
| FDA product code | CFJ |
| Device type | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1440 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2016-10-12 |
| Record revised | 2024-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R1 x 500mL, R2 x 125mL | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 10 |
| 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 |
Showing 12 of 60. All products under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
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.