HemoCue® Albumin 201 Analyzer
HemoCue Albumin 201 Analyzer mg/L
16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
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 | Hemocue AB, Sweden |
|---|---|
| FDA product code | KQO |
| Device type | Automated Urinalysis System |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature 32 to 122 °F; Storage environment temperature 0 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 120623 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053253 | 2006-02-17 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-16 | Class II | Packaging | HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches. | 10,356 boxes/50 microcuvettes | 2014-04-28 |
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.