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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device internal polymerase chain reaction control, not assay specific
Regulation Description Quality control material (assayed and unassayed).
Definition Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
Product CodeOLD
Regulation Number 862.1660
Device Class 1