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FDA product code NOT

Microscope, Automated, Image Analysis, Operator Intervention

HematologyClass 221 CFR 864.1860
Verified
US regulatory classifications
US Product Code (FDA)
NOT
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.1860
View CFR Regulation
Medical specialty
Hematology
Device characteristics
Implantable
No
Life-sustaining
No
Definition

Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.

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About this record

Microscope, Automated, Image Analysis, Operator Intervention is a medical device type in the Hematology 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.