Pure Global AI
FDA product code NCW

System, Test, Her-2/Neu, Monitoring

ImmunologyClass 221 CFR 866.6010
Verified
US regulatory classifications
US Product Code (FDA)
NCW
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.6010
View CFR Regulation
Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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About this record

System, Test, Her-2/Neu, Monitoring 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.