Biobase
6 catalogue numbers from R1:20mL×4 R2:5mL×4, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Alpha-1 Microglobulin, Antigen, Antiserum, Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Biobase Biodustry(Shandong)Co., Ltd., China |
|---|---|
| FDA product code | MGA |
| Device type | Alpha-1 Microglobulin, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5400 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1:20mL×4 R2:5mL×4 | In distribution | |
| Control:1mL×1 | In distribution | |
| R1:64mL×2 R2:16mL×2 | In distribution | |
| R1:64mL×5 R2:16mL×5 | In distribution | |
| R1:20mL×1 R2:5mL×1 | In distribution | |
| Calibrator:1mL×1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| K-Assay® Alpha-1 Microglobulin Reagent | Kamiya Biomedical Company LLC | 1 |
| Immage | Beckman Coulter, Inc. | 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.