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TPLC - Total Product Life Cycle

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Device meningitis/encephalitis pathogen multiplex nucleic acid detection system
Definition A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.
Product CodePLO
Regulation Number 866.3970
Device Class 2

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