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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test for detection of microorganism(s) causing sexually transmitted infections performed by lay users
Definition This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.
Product CodeSEA
Regulation Number 866.3386
Device Class 2


Premarket Reviews
ManufacturerDecision
VISBY MEDICAL, INC.
  GRANTED 1

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