Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr
2 catalogue numbers from 20 tests/kit, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China |
|---|---|
| FDA product code | OAM |
| Device type | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20 tests/kit | In distribution | |
| 5 tests/kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IGFBP-3 Elisa | Diasource Immunoassays, S.A. | 1 |
| Actim Prom Controls | Actim OY | 1 |
| IGF-1-RIA-CT | Diasource Immunoassays, S.A. | 1 |
| Actim Prom | Actim OY | 1 |
| IDS-iSYS SDSpeed Calc | Immunodiagnostic Systems Ltd. | 1 |
| IDS-iSYS Insulin like Growth Factor-1 (IGF-1) | Immunodiagnostic Systems Ltd. | 1 |
| IGF-1 Elisa | Diasource Immunoassays, S.A. | 1 |
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.