ABX Pentra Enzymatic Creatinine CP
ABX Pentra Enzymatic Creatinine CP is a laboratory reagent for measuring creatinine in human serum, plasma and urine. It is used with associated calibrator and control materials on the ABX…
ABX Pentra Enzymatic Creatinine CP is a laboratory reagent for measuring creatinine in human serum, plasma and urine. It is used with associated calibrator and control materials on the ABX Pentra 400 clinical chemistry analyzer. The test provides a quantitative creatinine result for clinical assessment.
The reagent uses a sequence of enzymatic reactions that ends in a photometric measurement. Creatinine measurements support the diagnosis and treatment of renal disease, monitoring of renal dialysis and calculations involving other urine analytes.
Laboratory Use
This is a prescription in vitro diagnostic reagent. Its role is to measure creatinine in a collected specimen, with calibration and quality control forming part of the analytical procedure.
Who Else Makes It
Concentrated in Zhejiang (1), Guangxi (1), Chongqing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Horiba ABX SAS, France |
|---|---|
| FDA product code | JFY |
| Device type | Enzymatic Method, Creatinine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1225 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110137 |
| Record published | 2016-08-16 |
| Record revised | 2022-12-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1220001907 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creatinine Plus | Roche Diagnostics Gmbh | 3 |
| Teco Diagnostics | Teco Diagnostics | 3 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Creatinine plus ver2 | Roche Diagnostics Gmbh | 3 |
| Architect | Abbott Laboratories | 2 |
| CR Cartridge | LifeHealth, LLC | 2 |
| Alinity | Abbott Laboratories | 2 |
| Creatinine LiquiColor® | Stanbio Laboratory, L.P. | 2 |
| Pointe Scientific, Inc. Creatinine Enzymatic | Horiba Instruments Incorporated | 2 |
| Automatic Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2 |
| Creatinine plus ver.2 | Roche Diagnostics Gmbh | 1 |
| Dimension® Flex® reagent cartridge Ezcr | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 40. All products under Enzymatic Method, Creatinine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193649 | 2021-05-10 |
| K110137 | 2011-08-10 |
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.