Von Willebrand Factor Assay

QTY · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7293

Classification

FDA Product Code: QTY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.7293
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown