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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood/plasma collection device for dna testing
Regulation Description Blood specimen collection device.
Definition A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Product CodePJE
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1

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