Elecsys IGFBp-3
2 catalogue numbers from 07574720190, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Human Growth Hormone. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | CFL |
| Device type | Radioimmunoassay, Human Growth Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1370 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-05 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07574720190 | In distribution | |
| 07574690190 | 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 |
| 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 |
| Human Growth Hormone (HGH) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 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.