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Assay, Proliferation, In Vitro, T Lymphocyte

FDA product code NID · 2 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.5220
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-04-02 – 2010-10-18

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.

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