LDH P-L
A lactate dehydrogenase test system is a device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum or plasma.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
2recalls on this code
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | CFJ |
| Device type | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K970684 |
| Record published | 2016-09-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Once reconstitued stable for 4 days at +2 to +8°C or 5 hours at +15 to +25°C.; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LD401 | In distribution | |
| LD3818 | 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 |
| Architect | Abbott Medical | 2 |
| AU | Beckman Coulter, Inc. | 2 |
Showing 12 of 60. All products under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970684 | 1997-05-07 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | 510(k) number | 2020-08-11 | Class II | Under Investigation by firm | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the t | 21 | 2020-10-15 |
| Randox Laboratories Limited | 510(k) number | 2020-08-11 | Class II | Under Investigation by firm | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the t | 4 | 2020-10-15 |
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.