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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, microbial growth monitor of normally sterile body fluid culture
Regulation Description Microbial growth monitor.
Definition Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
Product CodeQBQ
Regulation Number 866.2560
Device Class 1


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