K-Assay® Serum / Plasma Alpha-1 Microglobulin Calibrator
For the calibration of the K-ASSAY® Alpha-1 Microglobulin 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-068C | 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 |
| Immage | Beckman Coulter, Inc. | 1 |
| K-Assay® Urine 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.