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ANTI-dsDNA
ORGENTEC Diagnostika GmbH · Model ORG604 · UDI-DI 04260157080683
LRM
Prescription
10
510(k) clearances
109
Adverse events (2 deaths)
3
Recalls
14
Facilities
Description
Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
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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