Azostix® Reagent Strips
AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
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 | Siemens Healthcare Diagnostics 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K992257 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not store in direct sunlight.; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10324060 | 25 | 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 |
| 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 |
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.