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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeNQI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6020
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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