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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device flow cytometry calibrator
Regulation Description Automated differential cell counter.
Definition Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.
Product CodePDX
Regulation Number 864.5220
Device Class 2