QTY — Von Willebrand Factor Assay Class II
FDA product code QTY covers "Von Willebrand Factor Assay", a Class II medical device regulated under 21 CFR 864.7293. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200067 | siemens healthcare diagnostics products | INNOVANCE VWF Ac | September 29, 2022 |