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Control Material, Blood Circulating Epithelial Cancer Cell

FDA product code NRS · 1 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.8625
Review panel
HE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-06-28 – 2004-06-28

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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