NRS

Control Material, Blood Circulating Epithelial Cancer Cell

Product code

NRS

Device name

Control Material, Blood Circulating Epithelial Cancer Cell

Device class

Class 2

21 CFR

21 CFR 864.8625

Medical specialty

Hematology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.

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