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U.S. Department of Health and Human Services

Product Classification

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Device assay, proliferation, in vitro, t lymphocyte
Regulation Description Automated differential cell counter.
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.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeNID
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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