INNOVANCE Anti-Xa 10873942

GUDID 00630414640204

In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.

Siemens Healthcare Diagnostics Products GmbH

Coagulation factor Xa inhibitor/heparin activity reagent kit IVD

• Primary Device ID: 00630414640204
• NIH Device Record Key: 65b12a98-5e26-4e32-9088-5204bbed43d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVANCE Anti-Xa
• Version Model Number: 10873942
• Catalog Number: 10873942
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414640204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240315

FDA Product Code

• QLU: Anti-factor Xa activity test system, Apixaban

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: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [INNOVANCE Anti-Xa]

• 00630414240404: In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity
• 00630414640204: In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity