Estr-US
Radioimmunometric assay kit for the quantitative determination of low levels of estradiol in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Hebei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | Cisbio Bioassays |
|---|---|
| FDA product code | CHP |
| Device type | Radioimmunoassay, Estradiol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1260 |
| Premarket notification | Exempt |
| Record published | 2021-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESTR-US | 100 tests | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salimetrics | Salimetrics LLC. | 5 |
| MP Biomedicals LLC | Mp Biomedicals, LLC | 4 |
| 17beta-Estradiol Saliva Luminescence Immunoassay | IBL International Gmbh | 4 |
| Elecsys Estradiol III | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 3 |
| Advia Centaur® eE2 | Siemens Healthcare Diagnostics Inc | 3 |
| Architect | Abbott Ireland | 3 |
| Atellica IM eE2 | Siemens Healthcare Diagnostics Inc | 3 |
| Pantex | Pantex | 2 |
| Estradiol Sensitive Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Salivary Estradiol Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Ultrasensitive Estradiol Elisa | American Laboratory Products Company | 2 |
Showing 12 of 58. All products under Radioimmunoassay, Estradiol
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.