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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna fish probe kit for specimen characterization, human chromosome, hematological disorders
Definition DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
Product CodePFG
Regulation Number 864.1870
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

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