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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device severe combined immunodeficiency disorder (scid) newborn screening test system
Definition A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).
Product CodePJI
Regulation Number 866.5930
Device Class 2


Premarket Reviews
ManufacturerDecision
PERKINELMER INC
  SUBSTANTIALLY EQUIVALENT 1

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