FDA.reportPublic FDA data

Access OV Monitor

Primary DI
15099590232382
Brand
Access OV Monitor
Company
Beckman Coulter, Inc.
Model
386357
Catalog number
386357
Device description
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590232382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023238215099590232382

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method.

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
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
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336218327Elecsys CA 125 IIRoche Diagnostics GmbHLTK2024-08-13
10758750034826VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
10758750034901VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
00630414293493Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2020-05-31
00630414294278Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2020-05-31
00380740131043AlinityAbbott GmbHLTK2019-02-12
00816870020471CA-125 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870020488CA-125 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTK2019-02-11
00816870022154CA-125 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870022161CA-125 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTK2019-02-11
00380740145361ARCHITECTAbbott GmbHLTK2019-01-21
00380740145378ARCHITECTAbbott GmbHLTK2019-01-21
00380740145385ARCHITECTAbbott GmbHLTK2019-01-21
00380740131050AlinityAbbott GmbHLTK2018-12-31
00630414598116Atellica IM CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2017-12-27
00630414598086Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598093Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598109Atellica IM CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2017-12-22
04015630939633Elecsys CA 125 IIRoche Diagnostics GmbHLTK2017-04-14
14560189210216ST AIA-PACK CA 125TOSOH CORPORATIONLTK2016-09-24
04560189211131AIA-PACK CA 125 Sample Diluting SolutionTOSOH CORPORATIONLTK2016-09-24
04560189211148AIA-PACK CA 125 Calibrator SetTOSOH CORPORATIONLTK2016-09-24
00842768028519Dimension Vista® Flex® reagent cartridge CA125Siemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461274ADVIA Centaur® CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461298ADVIA Centaur® CA 125IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461304ADVIA Centaur® CA 125 IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461335ADVIA Centaur® Systems CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414954127IMMULITE®/IMMULITE® 1000 Systems OMM OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954134IMMULITE® 2000 Systems OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954219IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24