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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal muscular atrophy newborn screening test system
Definition A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing.
Product CodeQUE
Regulation Number 866.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
PERKINELMER INC.
  GRANTED 1

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