Vidas® Estradiol II
VIDAS ® Estradiol II (E2 II) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of total estradiol concentration in human serum or plasma.
5manufacturers in China registered for this device type
1catalogue number
3recalls on this code
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 | bioMerieux, Inc., United States |
|---|---|
| FDA product code | CHP |
| Device type | Radioimmunoassay, Estradiol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K955647 |
| Record published | 2019-10-03 |
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 | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30431-01 | 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| bioMerieux, Inc. | 510(k) number | 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 7 units | |
| bioMerieux, Inc. | UDI-DI | 2021-09-22 | Class II | Nonconforming Material/Component | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test. | One lot | |
| bioMerieux, Inc. | 510(k) number | 2017-03-17 | Class II | Device Design | Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant. | 834 kits | 2022-02-16 |
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.