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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis
Definition E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.
Product CodeOAH
Regulation Number 866.3740
Device Class 1