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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nucleic acid quantitation kit
Regulation Description Clinical sample concentrator.
Definition A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence or absorbance at a specified wavelength.
Product CodePEG
Regulation Number 862.2310
Device Class 1