Ichem Velocity
2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA) 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated…
2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA) 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA) “2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY” “2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)” “2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)” 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA) “2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)” “2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload” “2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)” “2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload” “2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)”
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 | Beckman Coulter Ireland Inc, Ireland |
|---|---|
| FDA product code | KQO |
| Device type | Automated Urinalysis System |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2900 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-07 |
| Record revised | 2023-10-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Elite/Stand-Alone Velocity (NA) | In distribution | |
| Back-Integrated Velocity (NA) | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | UDI-DI | 2019-10-28 | Class II | Software in the Use Environment | Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics). | 4314 devices | 2026-04-01 |
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.