IDS-iSYS Human Growth Hormone (hGH)
Catalogue number IS-3700, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Radioimmunoassay, Human Growth Hormone. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Immunodiagnostic Systems Ltd., United Kingdom |
|---|---|
| FDA product code | CFL |
| Device type | Radioimmunoassay, Human Growth Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1370 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-04-01 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Prior to first use. Store the cartridge and calibrators in an upright position in the dark. Do not freeze the cartridge; Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS-3700 | 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 |
| hGH Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| hGH AccuBind Elisa Test System – 192 Wells | Monobind, Inc. | 1 |
| Human Growth Hormone (HGH) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
Showing 12 of 45. All products under Radioimmunoassay, Human Growth Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950510 | 1995-04-05 |
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.