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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device breast milk-alcohol test system
Regulation Description Alcohol test system.
Definition Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.
Product CodeORA
Regulation Number 862.3040
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 Universal Meditech Inc. II Oct-23-2023
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