Immage
IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (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 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | MGA |
| Device type | Alpha-1 Microglobulin, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5400 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2023-08-28 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 447710 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 6 |
| K-Assay® Alpha-1 Microglobulin Reagent | Kamiya Biomedical Company LLC | 1 |
| K-Assay® Urine Alpha-1 Microglobulin Calibrator | Kamiya Biomedical Company LLC | 1 |
| K-Assay® Serum / Plasma Alpha-1 Microglobulin Calibrator | Kamiya Biomedical Company LLC | 1 |
| α1-Microglobulin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| a1-Microglobulin Elisa | DRG International, Inc. | 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.