FDA product code NQI

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Immunology·Class 2·21 CFR 866.6020
US regulatory classifications
US Product Code (FDA)
NQI
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.6020
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

System, Immunomagnetic, Circulating Cancer Cell, Enumeration is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.