IDS-iSYS SDSpeed Calc
Catalogue number IS-SDSCALC, listed by Immunodiagnostic Systems Ltd., United Kingdom, 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
1catalogue number
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 | Immunodiagnostic Systems Ltd., United Kingdom |
|---|---|
| FDA product code | OAM |
| Device type | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-27 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS-SDSCALC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 2 |
| 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 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.