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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home
Definition This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.
Product CodeQYA
Regulation Number 866.3385
Device Class 2


Premarket Reviews
ManufacturerDecision
LETSGETCHECKED INC. (FORMERLY PRIVAPATH DIAGNOSTICS INC.)
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