Rapid Response
The Rapid Response® U121S Urine Analyzer is intended for use in conjunction with the Rapid Response® Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human…
The Rapid Response® U121S Urine Analyzer is intended for use in conjunction with the Rapid Response® Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human urine. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. The instrument is intended for professional, in vitro diagnostic use only.
Who Else Makes It
Concentrated in Jilin (4), Shandong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| 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 |
Showing 12 of 16. All 16 manufacturers in China registered for Automated Urinalysis System
Record
| Listed by | Btnx Inc., Canada |
|---|---|
| FDA product code | KQO |
| Device type | Automated Urinalysis System |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2900 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K111221 |
| Record published | 2019-10-16 |
| Record revised | 2023-04-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UA-500 | In distribution | |
| UA-U121S | In distribution | |
| UA-U120S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iQ200 | Beckman Coulter Ireland Inc | 4 |
| Concentrated Washing Solution 3 | Arkray USA, Inc. | 2 |
| Aution™ Sticks 9EB – Test Strips | Arkray USA, Inc. | 2 |
| Clinitek Atlas® Control- Strips. | Siemens Healthcare Diagnostics Inc | 2 |
| My Yodoc | S-Connect Co., Ltd. | 2 |
| iChem Velocity | Beckman Coulter Ireland Inc | 2 |
| Mission U500 Urine Analyzer | Acon Laboratories, Inc. | 2 |
| Mission U120 Urine Analyzer | Acon Laboratories, Inc. | 2 |
| Aution EYE™ Control Solution H/L | Arkray USA, Inc. | 1 |
| Aution™ Diluent SED | Arkray USA, Inc. | 1 |
| DxU | Beckman Coulter, Inc. | 1 |
| UA Win10 Kit | Beckman Coulter Ireland Inc | 1 |
Showing 12 of 48. All products under Automated Urinalysis System
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.