Vitros
VITROS Immunodiagnostic Products Estradiol Reagent Pack
5manufacturers in China registered for this device type
1catalogue number
1recall
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 | Ortho-Clinical Diagnostics, 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 |
| Premarket notification | Exempt |
| Record published | 2020-04-01 |
| Record revised | 2025-02-19 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Do not freeze; Storage environment temperature 2 to 8 °C |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8552630 | 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
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 |
|---|---|---|---|---|---|
| 2016-07-14 | Class II | Device Design | Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent | Domestic: 1620; Foreign: 7597 | 2018-06-08 |
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.