Von Willebrand Factor Assay
The Von Willebrand Factor Assay is a prescription in vitro diagnostic device intended for the measurement of von Willebrand factor (vWF) activity or vWF size distribution in human plasma, used to aid in the diagnosis and management of von Willebrand disease, a common inherited bleeding disorder. Accurate measurement of vWF activity is essential for both diagnosis and monitoring of treatment response. Classified as FDA Class 2 under regulation 864.7293, it requires 510(k) clearance in the Hematology specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTY
- Device Class
- FDA class 2
- Regulation Number
- 864.7293
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200067 | INNOVANCE VWF Ac | Sep 29, 2022 | Unknown | Siemens Healthcare Diagnostics Products GmbH |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.