NID

Assay, Proliferation, In Vitro, T Lymphocyte

Product code

NID

Device name

Assay, Proliferation, In Vitro, T Lymphocyte

Device class

Class 2

21 CFR

21 CFR 864.5220

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).