AccessGUDID - DEVICE: Access anti-HBc IgM (15099590806323)

GUDID

Device Identifier (DI) Information

Brand Name: Access anti-HBc IgM
Version or Model: D22920
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D22920
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590806323
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-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other serological and clinical information. The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only. This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

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?
48298	Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays

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: 67a5bf7a-c6b9-4029-a687-ea723cb1ec9b
Public Version Date: May 12, 2026
Public Version Number: 1
DI Record Publish Date: May 04, 2026