Device
The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative
Manufacturer
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Model: D22920
Catalog: D22920
DI: 15099590806323
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
67a5bf7a-c6b9-4029-a687-ea723cb1ec9b
Distribution Status:
In Commercial Distribution
DUNS Number:
008254708
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
15099590806323
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 48298
Name: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Definition:
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.
FDA Product Codes
SEI
Qualitative And Quantitative Hepatitis B Virus Antibody Assays