Carolina Liquid Chemistries Corp.® CLC720 Creatinine Reagent KIT
CREA (Creatinine) 4 x 250 tests
4manufacturers in China registered for this device type
1catalogue number
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 | Carolina Liquid Chemistries, 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 |
| Record published | 2016-09-01 |
| Record revised | 2023-07-06 (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 | Special storage condition: Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C; Special storage condition: Unopened reagents are stable to expiration date with stored at 2 to 8°C; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 17 to 45 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST243 | Total Volume 45 ml | 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.