INNOVANCE Apixaban Standard 10874083

GUDID 00630414321844

For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated human plasma.

Siemens Healthcare Diagnostics Products GmbH

Coagulation factor Xa inhibitor IVD, calibrator

• Primary Device ID: 00630414321844
• NIH Device Record Key: 4ccbe51b-7f06-4630-acaa-4515e4c8fce3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVANCE Apixaban Standard
• Version Model Number: 10874083
• Catalog Number: 10874083
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414321844 [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

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

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• 00630414321844 - INNOVANCE Apixaban Standard: 2025-07-28For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated human plasma.
• 00630414321844 - INNOVANCE Apixaban Standard: 2025-07-28 For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated hu
• 00630414640204 - INNOVANCE Anti-Xa: 2025-07-28 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
• 00630414240336 - INNOVANCE Apixaban Controls: 2024-12-04 INNOVANCE Apixaban Controls
• 00630414240343 - INNOVANCE Apixaban Standards: 2024-12-04 INNOVANCE Apixaban Standards
• 00630414240404 - INNOVANCE Anti-Xa: 2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
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• 00842768019661 - LA 2 Confirmation Reagent: 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants