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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device newborn screening specimen collection paper
Definition Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Product CodePJC
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
PERKINELMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Agilent Technologies, Inc. II Apr-05-2017
2 PerkinElmer Health Sciences, Inc. III Jun-04-2020
3 PerkinElmer Health Sciences, Inc. III Jul-24-2017
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