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Anti-dsDNA IgM ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3564 · UDI-DI 04048474035643
LRM
Prescription
10
510(k) clearances
109
Adverse events (2 deaths)
3
Recalls
14
Facilities
Description
Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodies against double-stranded DNA (dsDNA) in human serum or plasma.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-03-02 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| 2010-03-02 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
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