Uri-Trak 120 M Urine Analyzer
The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in…
The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (2), Guangxi (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Showing 12 of 14. All 14 manufacturers in China registered for Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Record
| Listed by | Stanbio Laboratory, L.P. |
|---|---|
| FDA product code | JIR |
| Device type | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1645 |
| Record published | 2023-06-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G1300-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 12 |
| Teco Diagnostics | Teco Diagnostics | 5 |
| Rapid Response | Btnx Inc. | 3 |
| Cybow P | DFI Co., Ltd. | 2 |
| Total Protein (UP) | Randox Laboratories Limited | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Tinaquant Albumin | Roche Diagnostics Gmbh | 2 |
| Micro-albumin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Multistix® 9 SG Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Chemstrip Micral Urine Test Strips | Roche Diagnostics Gmbh | 1 |
| Micro Protein (CSF/Urine) LiquiColor® | Stanbio Laboratory, L.P. | 1 |
| Accutest | Jant Pharmacal Corp. | 1 |
Showing 12 of 36. All products under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
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.