Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test

• • Terminated Z-1383-2008 FDA Unclassified (pre-2012) ·initiated 25 Feb 2008

  Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).

510(k) Number

K070804 ↗

FDA Product Code

ODW

Device Class

Class II

Regulation

21 CFR Part 862.3360

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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