Carolina Liquid Chemistries Corp.® LDH RGT. KIT AU-205
LDH (Lactate Dehydrogenase) 3 x 300 tests
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Carolina Liquid Chemistries, 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 |
| Record published | 2016-09-01 |
| Record revised | 2018-03-29 (version 2) |
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 | Special storage condition: Reagent is stable on board a clinical analyzer for 30 days; Special storage condition: Reagent is stable when stored at 2-8° C until expiration date; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 9 to 60 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AU-205 | Total Volume 60 ml | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971398 | 1997-05-02 |
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.