FDA product code PBC

Manual Blood Grouping And Antibody Test Systems

Hematology·Class 2·21 CFR 864.9175
US regulatory classifications
US Product Code (FDA)
PBC
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.9175
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.

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About this record

Manual Blood Grouping And Antibody Test Systems 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.