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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood collection device for cell-free nucleic acid
Regulation Description Blood collection device for cell-free nucleic acids.
Definition A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.
Product CodeQMA
Regulation Number 862.1676
Device Class 2


Premarket Reviews
ManufacturerDecision
STRECK, INC.
  SUBSTANTIALLY EQUIVALENT 1

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