DeviceClearance

Product code NID— Hematology

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

Classification name
Assay, Proliferation, In Vitro, T Lymphocyte
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NID under 21 CFR 864.5220, via openFDA

Market context for product code NID

FDA has cleared 2 devices under product code NID between 2002 and 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NID

Recent clearances under product code NID

Data sourced from openFDA. This site is unofficial and independent of the FDA.