AccessGUDID - DEVICE: INNOVANCE Apixaban Controls (00630414321837)

GUDID

Device Identifier (DI) Information

Brand Name: INNOVANCE Apixaban Controls
Version or Model: 10874082
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10874082
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414321837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For quality control of the INNOVANCE ANTI-XA assay for the quantitativedetermination of apixaban in citrated human 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:	Yes
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?
56181	Coagulation factor Xa inhibitor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of activated coagulation factor Xa inhibitor in a clinical specimen.	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: 4f412102-bf86-431d-b1a2-a6b46963625e
Public Version Date: July 28, 2025
Public Version Number: 1
DI Record Publish Date: July 18, 2025