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TPLC - Total Product Life Cycle

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Device gastrointestinal bacterial panel multiplex nucleic acid-based assay system
Regulation Description Gastrointestinal microorganism multiplex nucleic acid-based assay.
Definition A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Product CodePCI
Regulation Number 866.3990
Device Class 2

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