AccessGUDID - DEVICE: ACCESS anti-HAV QC (15099590806439)

GUDID

Device Identifier (DI) Information

Brand Name: ACCESS anti-HAV QC
Version or Model: D25833
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590806439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access anti-HAV QC is intended for monitoring system performance of the Access anti-HAV assay. The Access anti-HAV QC is for use on the DxI 9000 Access Immunoassay Analyzer.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
41962	Hepatitis A virus total antibody 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 total antibodies to the Hepatitis A virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6cc2c8d6-b56f-438c-bbca-9270c4cbd7cc
Public Version Date: January 26, 2026
Public Version Number: 1
DI Record Publish Date: January 16, 2026