K-Assay® Alpha-1 Microglobulin Reagent
For the quantitative determination of human alpha-1 microglobulin in urine, serum and plasma by immunoturbidimetric assay.
3manufacturers in China registered for this device type
1catalogue number
1recall
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 | Kamiya Biomedical Company LLC, United States |
|---|---|
| FDA product code | MGA |
| Device type | Alpha-1 Microglobulin, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5400 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KAI-056 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 6 |
| 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 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-09-17 | Not classified | Employee error | Standardization of the reagent performance data did not match the standardization used to assign the calibrator values. | 5 kits | 2011-01-20 |
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.