Verigene CYP2C19 Nucleic Acid Tes (2C19)

• • Terminated Z-2559-2014 FDA Class III ·initiated 18 Mar 2014

  Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.

510(k) Number

K120466 ↗

FDA Product Code

NTI

Device Class

Class II

Regulation

21 CFR Part 862.3360

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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