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System, Immunomagnetic, Circulating Cancer Cell, Enumeration

FDA product code NQI · 12 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6020
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-03-15 – 2013-06-20

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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