HGH-US
Radioimmunometric assay kit for the quantitative determination of human growth hormone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| 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 | Cisbio Bioassays |
|---|---|
| FDA product code | CFL |
| Device type | Radioimmunoassay, Human Growth Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1370 |
| Premarket notification | Exempt |
| Record published | 2021-12-07 |
| Record revised | 2022-09-16 (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 |
| Storage | Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HGH-US | 100 tests | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elecsys hGH | Roche Diagnostics Gmbh | 2 |
| Elecsys IGF-1 | Roche Diagnostics Gmbh | 2 |
| IGF-1 600 Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| TGF-Beta 1 Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Elecsys IGFBp-3 | Roche Diagnostics Gmbh | 2 |
| TGF-Beta 2 Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| AIA-Pack HGH Calibrator Set | Tosoh Corp. | 1 |
| hGH AccuLite Clia Test System – 192 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems IGFBP-3 | Siemens Healthcare Diagnostics Products GmbH | 1 |
| IDS-iSYS Human Growth Hormone (hGH) | Immunodiagnostic Systems Ltd. | 1 |
| hGH Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| hGH AccuBind Elisa Test System – 192 Wells | Monobind, Inc. | 1 |
Showing 12 of 45. All products under Radioimmunoassay, Human Growth 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.