FDA.reportPublic FDA data

ACCESS HIV Ag/Ab combo QC

Primary DI
15099590745172
Brand
ACCESS HIV Ag/Ab combo QC
Company
Beckman Coulter, Inc.
Model
C39452
Catalog number
C39452
Device description
The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV Ag/Ab combo QC is for use on the DxI 9000 Access Immunoassay Analyzer.
Published
2024-03-15
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
CodeName
MJXKit, Serological, Positive Control
MJYKit, Serological, Negative Control
MJZKit, Direct Antigen, Positive Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJXKit, Serological, Positive ControlClinical Chemistry1
MJYKit, Serological, Negative ControlClinical Chemistry1
MJZKit, Direct Antigen, Positive ControlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590745172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959074517215099590745172

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antigen/antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.

Sterilization Methods#

Method table
Method

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
15099590799243MicroScanV5.03 PU11ED233522025-12-08
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
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816862027303WELLlife™WONDFO USA CO., LTD.MJZ2026-06-01
30014613340768QuickVue™WONDFO USA CO., LTD.MJZ2025-10-31
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOSANG HEALTHCARE Co., Ltd.MJZ2025-03-12
10845357043754Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.MJZ2022-02-16
00840733103476RSV Positive ControlMERIDIAN BIOSCIENCE, INC.MJX2021-06-18
00380740131364AlinityAbbott GmbHMJY2020-11-06
00380740131364AlinityAbbott GmbHMJX2020-11-06
10758750001149VITROSORTHO CLINICAL DIAGNOSTICSMJX2020-04-01
05055273216387SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)RANDOX LABORATORIES LIMITEDMJY2020-01-22
05055273216394SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)RANDOX LABORATORIES LIMITEDMJX2020-01-22
00816784020413ACCURUN®Lgc Clinical Diagnostics, Inc.MJX2018-09-24
00380740011161ARCHITECTAbbott GmbHMJY2016-09-09
00380740011161ARCHITECTAbbott GmbHMJX2016-09-09
00380740011178ARCHITECTAbbott GmbHMJX2016-09-09
00380740011178ARCHITECTAbbott GmbHMJY2016-09-09
00380740011185ARCHITECTAbbott GmbHMJY2016-09-09
00380740011185ARCHITECTAbbott GmbHMJX2016-09-09
10811877010712BinaxNOW® Malaria Positive Control KitAlere Scarborough, Inc.MJZ2016-09-03