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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, proliferation, in vitro, t lymphocyte
Definition A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.
Product CodeNID
Regulation Number 864.5220
Device Class 2