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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multiple use blood lancet for multiple patient use
Regulation Description Blood lancets.
Definition A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Product CodeQRM
Regulation Number 878.4850
Device Class 3

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