Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test Kit

• 2 recalls, same reason

  • Terminated Z-1648-2011 FDA Unclassified (pre-2012) ·initiated 2 Mar 2010
  • Terminated Z-1647-2011 FDA Unclassified (pre-2012) ·initiated 2 Mar 2010

  The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.

510(k) Number

K960091 ↗

FDA Product Code

LRM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Anti-Ss-B/La Antibody Test

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• Anti-Dsdna Antibody Test

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• Enzyme Immunoassay Anti-SS-A/Ro Antibody Test Kit

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• Enzyme Immunoassay Anti-Sm Antibody Test Kit

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