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TPLC - Total Product Life Cycle

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Device manual blood grouping and antibody test systems
Regulation Description Automated blood grouping and antibody test system.
Definition A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Product CodePBC
Regulation Number 864.9175
Device Class 2

Device Problems
False negative result 1
Total Device Problems 1

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