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FDA product code QHS

Anti-Human Globulin

HematologyClass U21 CFR 660.50
US regulatory classifications
US Product Code (FDA)
QHS
US Risk Class (FDA)
Class U
US Regulation (CFR)
21 CFR 660.50
Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology

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About this record

Anti-Human Globulin 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.