Aution™ Sheath Solution
Catalogue number 73811, listed by Arkray USA, Inc., United States, under Automated Urinalysis System. 16 manufacturers in China are registered for this product code.
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 | Arkray USA, Inc., United States |
|---|---|
| FDA product code | KQO |
| Device type | Automated Urinalysis System |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2900 |
| 510(k) | K121456 |
| Record published | 2016-09-23 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 73811 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iQ200 | Beckman Coulter Ireland Inc | 4 |
| Rapid Response | Btnx Inc. | 3 |
| 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 |
Showing 12 of 48. All products under Automated Urinalysis System
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 |
|---|---|---|---|---|---|---|---|
| Arkray Factory USA, Inc. | 510(k) number | 2019-05-03 | Class II | Software design | This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No | 159 units | 2020-09-17 |
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.