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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fungal organisms, nucleic acid-based assay
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Product CodePEO
Regulation Number 866.3365
Device Class 2

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