FDA.reportPublic FDA data

Access anti-HAV IgM Calibrator

Primary DI
15099590806453
Brand
Access anti-HAV IgM Calibrator
Company
Beckman Coulter, Inc.
Model
D25835
Catalog number
D25835
Device description
The Access anti-HAV IgM Calibrator is intended to calibrate the Access anti-HAV IgM assay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QCHAssayed Quality Control Material For Clinical Microbiology Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCHAssayed Quality Control Material For Clinical Microbiology AssaysMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590806453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959080645315099590806453

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibratorA 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 A virus 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16
15099590806422ACCESS anti-HAV CALIBRATORD258322026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391523442121Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442251Multichem ID-HIV p24 Mini KitTECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442435Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
00380740197643AlinityAbbott GmbHQCH2023-11-04
00380740174347AlinityAbbott GmbHQCH2022-11-26
08056771602976LIAISON MeMed BV Control SetDiasorin Inc.QCH2022-08-10
00630414607054DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414298405DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414247014ADVIA Centaur Zika IgM QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414247038ADVIA Centaur Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286846Atellica IM Zika IgM ControlsSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286860Atellica IM Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
08056771602648LIAISON® XL Zika Capture IgM II Control SetDiasorin Inc.QCH2019-12-04
07613336129746PreciControl Anti-HAV IIRoche Diagnostics GmbHQCH2019-09-30
00630414587448ADVIA Centaur CMV IgG QCSiemens Healthcare Diagnostics Inc.QCH2019-02-10
00630414246482Atellica IM CMV IgG Quality ControlSiemens Healthcare Diagnostics Inc.QCH2018-11-30