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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device for home collection and transport of specimens by lay users for use in a cleared non-viral sti molecular assay
Definition A device for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay is a device intended for use by lay users in home settings or similar environments for the collection and transportation of specimens for testing using a cleared non-viral STI molecular assay with which the device has been validated.
Product CodeSIH
Regulation Number 866.2920
Device Class 2


Premarket Reviews
ManufacturerDecision
DNA GENOTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1

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