INNOVANCE Anti-Xa

Basic Information

• Brand Name: INNOVANCE Anti-Xa
• Primary DI: 00630414240404
• Version / Model: 10873681
• Catalog Number: OPPU05
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-26
• Public Version: 2
• Public Version Date: 2025-05-20
• Public Version Status: Update
• Public Device Record Key: ade894f1-1f90-41d3-b551-62920eed4e2c

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QLU	Anti-factor Xa activity test system, Apixaban	Hematology	864.7295	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65560	Coagulation factor Xa inhibitor/heparin activity reagent kit IVD	A collection of reagents intended to be used for the quantitative detection of heparin activity by measuring the ability of heparin to inhibit activated coagulation factor X (factor Xa) and for the qualitative and/or quantitative detection of factor Xa inhibitors, in a clinical specimen. The assay is used to monitor anticoagulation therapy with heparin and/or as an aid to diagnose/determine anticoagulant status during therapy with factor Xa direct inhibitors (e.g., rivaroxaban, apixaban).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414240404	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240315	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius