NRS

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Control Material, Blood Circulating Epithelial Cancer Cell

Device class

Class II (moderate risk)

Regulation

21 CFR 864.8625

Medical specialty

Hematology

FDA 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.

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