FSH, hCG, LH & PRLs Vast AccuBind Elisa Test System – 960 Wells
3 catalogue numbers from 8325-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product 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 | Monobind, Inc., United States |
|---|---|
| FDA product code | CGJ |
| Device type | Radioimmunoassay, Follicle-Stimulating Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1300 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2024-09-16 (version 2) |
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 | Storage environment temperature 2 to 8 °C |
| Sizes | Width 7.75 to 12 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8325-300 | Width 12 in | In distribution |
| 8325-300 | Width 12 in | In distribution |
| 8325-300 | Width 7.75 in | 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 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 |
| Lumipulse G FSH-N Immunoreaction Cartridges | Fujirebio Inc. | 1 |
Showing 12 of 42. All products under Radioimmunoassay, Follicle-Stimulating Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972720 | 1997-09-02 |
| K820048 | 1982-02-04 |
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.