INNOVANCE VWF Ac OPHL035

GUDID 00842768028014

In-vitro diagnostic automated assay for the quantitative determination of the von Willebrandfactor-GPIb-binding activity in humanplasma collected from venous blood samples in 3.2%sodium citrate tube.

Siemens Healthcare Diagnostics Products GmbH

von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00842768028014
• NIH Device Record Key: 639e8af4-896e-4d75-b26b-d8693b93e805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVANCE VWF Ac
• Version Model Number: 10487040
• Catalog Number: OPHL035
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768028014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200067

FDA Product Code

• QTY: von Willebrand factor assay

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-18
• Device Publish Date: 2022-10-10

On-Brand Devices [INNOVANCE VWF Ac]

• 00842768028014: In-vitro diagnostic automated assay for the quantitative determination of the von Willebrandfact
• 00630414639468: For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in huma