AU
2 catalogue numbers from OSR6127, listed by Beckman Coulter, Inc., United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | Beckman Coulter, 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, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-07-06 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSR6127 | In distribution | |
| OSR6227 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-03 | Class II | Under Investigation by firm | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results. | 92,837 units total (71,271 units in US) | 2018-05-31 |
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.