Alinity
Alinity i FSH Reagent Kit 1200 Tests
6manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Abbott Ireland, Ireland |
|---|---|
| FDA product code | CGJ |
| Device type | Radioimmunoassay, Follicle-Stimulating Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1300 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-04 |
| Record revised | 2023-10-09 (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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07P4930 | In distribution | |
| 07P4920 | 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 |
| 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
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.