Stat Profile
Prime/StatProfile pHOx Ultra/CCX Magnets for Capillary Tubes 10 per vial
12manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Nova Biomedical Corporation, United States |
|---|---|
| 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 | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110648 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| pHOx Ultra/CCX | In distribution | ||
| Prime/pHOx Ultra/CCX | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 3 |
| Rapid Response | Btnx Inc. | 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 |
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.