AccessGUDID - DEVICE: INNOVANCE Anti-Xa (00630414240404)

GUDID

Device Identifier (DI) Information

Brand Name: INNOVANCE Anti-Xa
Version or Model: 10873681
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPPU05
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414240404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLU	Anti-factor Xa activity test system, Apixaban

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240315	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ade894f1-1f90-41d3-b551-62920eed4e2c
Public Version Date: May 20, 2025
Public Version Number: 2
DI Record Publish Date: November 26, 2024