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Alpha-1 Microglobulin, Antigen, Antiserum, Control
FDA product code MGA · Class 1 · Immunology
12
Registered devices
0
Adverse events
1
Recalls
2
510(k) clearances
Devices with this code
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.K-ASSAY® Alpha-1 Microglobulin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.α1-Microglobulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungK-ASSAY® Serum / Plasma Alpha-1 Microglobulin Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCK-ASSAY® Urine Alpha-1 Microglobulin Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCa1-Microglobulin ELISA — DRG International IncBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.IMMAGE — Beckman Coulter, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-09-17 | Kamiya Biomedical Company, LLC | Standardization of the reagent performance data did not match the standardization used to assign the calibrator values. |
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