FDA product code QSA

Circulating Tumor Cell (Ctc) Enrichment Device

Immunology·Class 2·21 CFR 866.6110
US regulatory classifications
US Product Code (FDA)
QSA
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.6110
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.

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About this record

Circulating Tumor Cell (Ctc) Enrichment Device is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.