Fully-Automated Urine Chemistry Analyzer
Catalogue number DxU 1800c,1 unit, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.
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 | Urit Medical Electronic Co., Ltd., China |
|---|---|
| FDA product code | JFY |
| Device type | Enzymatic Method, Creatinine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1225 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K232317 |
| Record published | 2026-06-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 55 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DxU 1800c,1 unit | 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.