QTY — Von Willebrand Factor Assay Class II

FDA Device Classification

Classification Details

Product Code
QTY
Device Class
Class II
Regulation Number
864.7293
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN200067siemens healthcare diagnostics productsINNOVANCE VWF AcSeptember 29, 2022