Immulite®/Immulite® 1000 Systems BP3 IGFBP-3
IGF BP3 - IMMULITE - RGT - 100 Tests
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 | Siemens Healthcare Diagnostics Products 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10381425 | 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.