Rapid Response
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood,…
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) – 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
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 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Btnx Inc., Canada |
|---|---|
| FDA product code | JJB |
| Device type | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1115 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K061559 |
| Record published | 2016-10-17 |
| Record revised | 2023-04-20 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| U10.1-1S100 | 100 | In distribution | |
| U10.1-1S25 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 3 |
| Stat Profile | Nova Biomedical Corporation | 2 |
| Clinitek Status Connector | Siemens Healthcare Diagnostics Inc | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| Ictotest® Reagent Tablets and Mats for Urinalysis | Siemens Healthcare Diagnostics Inc | 1 |
| Urine Analyzer | Urit Medical Electronic Co., Ltd. | 1 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
| DxU | Beckman Coulter, Inc. | 1 |
| Diazo-Chek | Biorex Labs LLC | 1 |
| iChem® Velocity™ | Beckman Coulter Ireland Inc | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Clarity Diagnostics, LLC | 510(k) number | 2018-06-22 | Class III | Labeling design | Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label. | 7536 Bottles | 2024-01-12 |
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.