Access hFSH
The Access hFSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of follicle stimulating hormone (FSH) levels in human serum and plasma…
The Access hFSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of follicle stimulating hormone (FSH) levels in human serum and plasma using the Access Immunoassay Systems.
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 | Beckman Coulter, 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, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-26 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33520 | 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 |
| AIA-Pack FSH Calibrator Set | Tosoh Corp. | 1 |
| Lumipulse G FSH-N Immunoreaction Cartridges | Fujirebio Inc. | 1 |
Showing 12 of 42. All products under Radioimmunoassay, Follicle-Stimulating Hormone
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.