Vivoo At-Home Urinary Tract Infection Test
UTI Test
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (4), 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 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| 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 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Showing 12 of 14. All 14 manufacturers in China registered for Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Record
| Listed by | Vivosens Inc, United States |
|---|---|
| FDA product code | JMT |
| Device type | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1510 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2024-11-25 |
| Record revised | 2026-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Storage | Storage environment temperature 36 to 86 °F; Special storage condition: Keep out of direct sunlight |
| Packaging | Carton of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VI25V1 | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 9 |
| Starling Medical, Inc | Starling Medical | 3 |
| Teco Diagnostics | Teco Diagnostics | 3 |
| S.G. Calibrator H | Arkray USA, Inc. | 2 |
| Rapid Response | Btnx Inc. | 2 |
| Medline | Medline Industries, Inc. | 1 |
| Leader | Cardinal Health 110, Inc. | 1 |
| Clinistix UTI Test Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Clinitek Novus® Cal 1-4 kit | Siemens Healthcare Diagnostics Inc | 1 |
| NEW Choice | SCI Medic, Inc. | 1 |
| GenaCheck Rapid Self-Test Kit For Urinary Tract Infections | Genabio Diagnostics Inc | 1 |
| DrugTect Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 1 |
Showing 12 of 25. All products under Diazo (Colorimetric), Nitrite (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.