NQI

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Product code

NQI

Device name

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Device class

Class 2

21 CFR

21 CFR 866.6020

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

13 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).