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DNA (ds) IgG ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2774 · UDI-DI 04048474027747
LJM
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Description
The dsDNA ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to |
| 2008-08-19 | Zeus Scientific Inc | The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266. |
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