For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma

For the quantitative determination of von Willenbrand factor (VWF) GPIb
INNOVANCE VWF Ac - 10487040

A collection of reagents and other associated materials intended to be used for the quantitative measurement of von Willebrand factor: glycoprotein Ib binding activity (vWF:GPIb) in a clinical specimen, using a nephelometry/turbidimetry method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QTY

Device Name: Von Willebrand Factor Assay

Device Class: 2

Physical State: VWF activity test system containing reagents, automated coagulometer, controls and calibrators

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.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The tests detect the binding of VWF to its receptor Glycoprotein Ib (GPIb) which induces a particle agglutination which can be measured as an increase in extinction by turbidimetric measurements.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral human whole blood (citrated plasma)

Regulation Number: 864.7293

Third Party Flag: N

Medical Specialty: HE

Device Id: 00842768028014

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A