IDS High Sensitive Estradiol
For In Vitro Diagnostic Use. For Laboratory Professional Use. IDS High Sensitive Estradiol assay is an automated in vitro diagnostic device intended for the quantitative determination of…
For In Vitro Diagnostic Use. For Laboratory Professional Use. IDS High Sensitive Estradiol assay is an automated in vitro diagnostic device intended for the quantitative determination of estradiol in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis and monitoring of estrogen disorders in the adult men and postmenopausal women, and paediatric population.
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 | Immunodiagnostic Systems Ltd., United Kingdom |
|---|---|
| FDA product code | CHP |
| Device type | Radioimmunoassay, Estradiol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1260 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-25 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS-5200HS | 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.