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TPLC - Total Product Life Cycle
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Device muscular dystrophy newborn screening test
Definition A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.
Product CodeQJE
Regulation Number 862.1506
Device Class 2


Premarket Reviews
ManufacturerDecision
PERKINELMER INC.
  GRANTED 1

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