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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, microarray-based, genome-wide, postnatal chromosomal abnormality detection
Definition A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other clinical information currently used in postnatal diagnosis. It is not intended to be used for standalone diagnostic purposes, prenatal or pre-implantation testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.
Product CodePFX
Regulation Number 866.5920
Device Class 2


Premarket Reviews
ManufacturerDecision
AFFYMETRIX, INC.
  GRANTED 1
AGILENT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Affymetrix Inc III Jun-03-2016
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