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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, immunomagnetic, circulating cancer cell, enumeration
Regulation Description Immunomagnetic circulating cancer cell selection and enumeration system.
Definition In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.
Product CodeNQI
Regulation Number 866.6020
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 Menarini Silicon Biosystems II Jul-07-2022
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