QTY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Von Willebrand Factor Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7293
- Medical specialty
- Hematology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| INNOVANCE VWF Ac (DEN200067) | Siemens Healthcare Diagnostics Products GmbH | 2022-09-29 |
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Every clearance here is in the API, with alerts when new ones post.