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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drug metabolizing enzyme genotyping systems
Regulation Description Drug metabolizing enzyme genotyping system.
Definition Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.
Product CodeNTI
Regulation Number 862.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX MOLECULAR DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

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