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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device self-contained blood grouping
Regulation Description Automated blood grouping and antibody test system.
Definition Intended for single use for individual blood group determination for educational and informational purposes
Product CodeOQX
Regulation Number 864.9175
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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