Teco Diagnostics
URS-9-100 Generic Finished KIT
14manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Teco Diagnostics, United States |
|---|---|
| FDA product code | JMT |
| Device type | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1510 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K954977 |
| Record published | 2017-01-05 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URS-9-100 GENERIC | In distribution | |
| URS-9-100 | In distribution | |
| URS-9-100 BOTTLE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 9 |
| Starling Medical, Inc | Starling Medical | 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 |
| Vivoo At-Home Urinary Tract Infection Test | Vivosens 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170118 | 2017-09-21 |
| K100024 | 2011-02-17 |
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.