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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device over-the-counter molecular multi-analyte respiratory virus detection test
Definition An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Product CodeSIA
Regulation Number 866.3984
Device Class 2


Premarket Reviews
ManufacturerDecision
VISBY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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