Vidas® FSH
VIDAS® FSH (FSH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of FSH concentration in human serum or plasma
6manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Hebei (1), Hunan (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 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | 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 | CGJ |
| Device type | Radioimmunoassay, Follicle-Stimulating Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K921746 |
| Record published | 2019-09-25 |
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 |
|---|---|---|
| 30407-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elecsys FSH | Roche Diagnostics Gmbh | 5 |
| Atellica IM FSH | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® FSH | Siemens Healthcare Diagnostics Inc | 3 |
| FSH, hCG, LH & PRLs Vast AccuBind Elisa Test System – 960 Wells | Monobind, Inc. | 3 |
| FSH Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 3 |
| Monobind AccuLite FSH, hCG, LH & PRLs Vast Clia Kit – 960 Wells | Monobind, Inc. | 3 |
| Immulite® 2000 Systems FSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Architect | Abbott Ireland | 2 |
| Alinity | Abbott Ireland | 2 |
| FSH Elisa | DRG International, Inc. | 2 |
| Access hFSH | Beckman Coulter, Inc. | 1 |
| AIA-Pack FSH Calibrator Set | Tosoh Corp. | 1 |
Showing 12 of 42. All products under Radioimmunoassay, Follicle-Stimulating Hormone
Recalls Naming This Product
2 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. | 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 | 2018-04-09 | Class II | Under Investigation by firm | Invalid calibration with low calibrator S1 while using the product. | 59 units distributed to the U.S. | 2025-12-02 |
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.