DeviceClearance

Product code QTY— Hematology

INNOVANCE VWF Ac

Classification name
Von Willebrand Factor Assay
Device class
Class 2
Regulation
21 CFR 864.7293
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QTY under 21 CFR 864.7293, via openFDA

Market context for product code QTY

FDA has cleared 1 device under product code QTY, all in 2022, 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.

Top applicants under product code QTY

Recent clearances under product code QTY

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