Pointe Creatinine Enzymatic on BS480
Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic…
Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only.
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 Instruments Incorporated, United States |
|---|---|
| FDA product code | JFY |
| Device type | Enzymatic Method, Creatinine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1225 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K050283 |
| Record published | 2020-05-28 |
| Record revised | 2025-10-02 (version 3) |
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 | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-C7548-216 | 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
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.