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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated platform consisting of software and instrumentation for pooling and/or lysing donor blood, serum, or plasma
Regulation Description Pipetting and diluting system for clinical use.
Definition Instrument used to create pools of whole blood, whole blood lysates, serum, and /or plasma, for use in blood donor screening tests. May include sample preparation steps such as lysing of whole blood samples.
Product CodeQBZ
Regulation Number 862.2750
Device Class 1