QTY

Von Willebrand Factor Assay

Product code: QTY
Device name: Von Willebrand Factor Assay
Device class: Class 2
21 CFR: 21 CFR 864.7293
Medical specialty: Hematology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

A von Willebrand factor assay is a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma.

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

Official FDA classification page: QTY

Classification and pathway per current FDA publications. Data from openFDA (CC0).