Mission Urinalysis Reagent Strips
Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
11manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (5), Zhejiang (2), Guangxi (1). 3 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 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| 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 |
Record
| Listed by | Acon Laboratories, Inc., United States |
|---|---|
| FDA product code | CDM |
| Device type | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1785 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-06-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight; Special storage condition: Store in a cool, dry place; Storage environment temperature 36 to 86 °F |
| Packaging | Carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| U031-091 | 100 | In distribution | |
| U031-081 | 100 | In distribution | |
| U031-051 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pro Advantage | National Distribution & Contracting Inc | 4 |
| Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
| Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2 |
| Ricca Chemical Company® | Ricca Chemical Company LLC | 2 |
| Cybow 11 | DFI Co., Ltd. | 1 |
| Mission U120 Touch Urine Analyzer | Acon Laboratories, Inc. | 1 |
| Aution™ Sticks 10EA Test Strips | Arkray USA, Inc. | 1 |
| URiSCAN 10 SGL strip | YD Diagnostics | 1 |
| Areta 10 Parameters Urinalysis Reagent Strips （50 tests kit） | Easy Healthcare Corporation | 1 |
| Chemstrip 7 Test Strips | Roche Diagnostics Gmbh | 1 |
| Chemstrip 5 OB Test Strips | Roche Diagnostics Gmbh | 1 |
Showing 12 of 26. All products under Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061559 | 2006-08-11 |
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.