Device
The Access anti-HBc IgM Calibrator is intended to calibrate the Access anti-HBc IgM assay for the in vitro qualitative
Manufacturer
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Model: D22921
Catalog: D22921
DI: 15099590806330
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 Calibrator is intended to calibrate the Access anti-HBc IgM assay for the in vitro qualitative
detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human serum and plasma using the DxI
9000 Access Immunoassay Analyzer.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9dcd5f18-e101-4b80-8088-5e8c5ab0e257
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:
15099590806330
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41981
Name: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
Definition:
A material which is used to establish known points of reference for an assay 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.
FDA Product Codes
SEI
Qualitative And Quantitative Hepatitis B Virus Antibody Assays