PBC

Manual Blood Grouping And Antibody Test Systems

Product code
PBC
Device name
Manual Blood Grouping And Antibody Test Systems
Device class
Class 2
21 CFR
21 CFR 864.9175
Medical specialty
Hematology
Marketing pathway
510(K)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PBC
Classification and pathway per current FDA publications. Data from openFDA (CC0).