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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, rna, yeast
Regulation Description Microorganism differentiation and identification device.
Definition Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Product CodeNZS
Regulation Number 866.2660
Device Class 1

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