QTY · Von Willebrand Factor Assay
Hematology · 21 CFR 864.7293 · Class 2
Overview
| Product Code | QTY |
|---|---|
| Device Name | Von Willebrand Factor Assay |
| Regulation | 21 CFR 864.7293 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
The INNOVANCE VWF Ac assay is an in-vitro diagnostic automated, particle-enhanced turbidimetric assay for the quantitative determination of von Willebrand factor (VWF)-GPIb-binding activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS XP System. It is intended as an aid in the evaluation of patients with suspected or confirmed von Willebrand factor disorders.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the identified risks.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN200067 | INNOVANCE VWF Ac | Siemens Healthcare Diagnostics Products GmbH | Sep 29, 2022 | DENG |
Top Applicants
- Siemens Healthcare Diagnostics Products GmbH — 1 clearance
