Home GUDID 15099590806330 Access anti-HBc IgM Calibrator
Primary DI 15099590806330
Brand Access anti-HBc IgM Calibrator
Company Beckman Coulter, Inc.
Model D22921
Catalog number D22921
Device description The Access anti-HBc IgM Calibrator is intended to calibrate the Access anti-HBc IgM assay for the in vitro qualitativedetection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human serum and plasma using the DxI9000 Access Immunoassay Analyzer.
Published 2026-05-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15099590806330 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15099590806330 15099590806330
GMDN Terms# Term, Definition table Term Definition Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator 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.
Regulatory Flags# DUNS number 008254708 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 15099590806323 Access anti-HBc IgM Beckman Coulter, Inc. SEI 2026-05-04 15099590806347 Access anti-HBc IgM QC Beckman Coulter, Inc. SEI 2026-05-04 15099590806293 Hepatitis B Virus core Total Antibody Beckman Coulter, Inc. SEI 2026-03-30 15099590806309 ACCESS anti-HBc Total CALIBRATOR Beckman Coulter, Inc. SEI 2026-03-30 15099590806316 ACCESS anti-HBc Total QC Beckman Coulter, Inc. SEI 2026-03-30 00630414637877 Atellica IM HBcT2 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2024-04-26 00630414561233 ADVIA Centaur® HBcT2 Quality Control Kit SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2023-06-20 00630414561226 ADVIA Centaur® HBcT2 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2023-06-20 00630414210766 ADVIA Centaur® HBcT2 Quality Control Kit SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2023-06-20 00630414604138 Atellica IM HBcT2 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2023-06-20 00630414604336 Atellica IM HBcT2 QC SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2023-06-20 00842768022678 Atellica IM aHBe2 Siemens Healthcare Diagnostics Inc. SEI 2022-05-05 00630414167923 ADVIA Centaur aHBe2 50T Kit Siemens Healthcare Diagnostics Inc. SEI 2022-01-14 00630414301266 Atellica IM aHBcM Siemens Healthcare Diagnostics Inc. SEI 2021-01-15 00630414301273 Atellica IM aHBs2 Siemens Healthcare Diagnostics Inc. SEI 2021-01-15 00630414301303 Atellica IM HBcT Siemens Healthcare Diagnostics Inc. SEI 2021-01-15 00630414597799 Atellica™ IM aHBcM Siemens Healthcare Diagnostics Inc. SEI 2018-10-16 00630414597805 Atellica™ IM aHBcM QC Siemens Healthcare Diagnostics Inc. SEI 2018-10-16 00630414597836 Atellica™ IM aHBs2 Siemens Healthcare Diagnostics Inc. SEI 2018-10-16 00630414597843 Atellica™ IM aHBs2 QC Siemens Healthcare Diagnostics Inc. SEI 2018-10-16 00630414599205 Atellica™ IM HBcT Siemens Healthcare Diagnostics Inc. SEI 2018-10-16 00630414599212 Atellica™ IM HBcT QC Siemens Healthcare Diagnostics Inc. SEI 2018-10-16 00630414470498 ADVIA Centaur® HBc IgM Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414470504 ADVIA Centaur® Systems HBc IgM QC Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414498089 ADVIA Centaur® Systems HBcT QC Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414498096 ADVIA Centaur® HBcT Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414551777 ADVIA Centaur® Systems aHBs2 QC Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414561790 ADVIA Centaur® aHBs2 Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414591407 ADVIA Centaur® aHBs2 Siemens Healthcare Diagnostics Inc. SEI 2014-09-24 00630414970981 IMMULITE® 2000 Systems aBC Anti-HBc SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD SEI 2014-09-24