QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

• • Ongoing Z-1358-2024 FDA Class II ·initiated 15 Feb 2024

  Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

510(k) Number

K181661 ↗

FDA Product Code

OYX

Device Class

Class II

Regulation

21 CFR Part 866.6060

Advisory Committee

Medical Genetics

FDA Decision

SESE Substantially Equivalent

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