FDA.reportPublic FDA data

Access Folate

Primary DI
15099590209308
Brand
Access Folate
Company
Beckman Coulter, Inc.
Model
A98032
Catalog number
A98032
Device description
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, and plasma (heparin) or red blood cells 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
CGNAcid, Folic, Radioimmunoassay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGNAcid, Folic, RadioimmunoassayClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590209308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959020930815099590209308

GMDN Terms#

Term, Definition table
TermDefinition
Folate (vitamin B9) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of folate (vitamin B9) 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
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414293653Atellica IM FolSiemens Healthcare Diagnostics Inc.CGN2020-05-31
00380740136567AlinityABBOTT IRELANDCGN2019-02-12
00816870020327Folate AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870020334Monobind AccuBind Folate ELISA Kit - 192 WellsMONOBIND, INC.CGN2019-02-11
00816870022000Folate AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870022017Folate AccuLite CLIA Test System -192 WellsMONOBIND, INC.CGN2019-02-11
00630414469454ADVIA Centaur® FOL (25-pack)Siemens Healthcare Diagnostics Inc.CGN2018-12-01
00380740130923AlinityABBOTT IRELANDCGN2018-11-12
00380740136550AlinityABBOTT IRELANDCGN2018-11-12
00630414597690Atellica™ IM RBC FOLSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598963Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598970Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598987Atellica™ IM Fol DILSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598994Atellica™ IM Fol MCMSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414599007Atellica™ IM Fol DTT/Releasing AgentSiemens Healthcare Diagnostics Inc.CGN2018-06-05
04015630939695Elecsys FolateRoche Diagnostics GmbHCGN2017-04-21
00817830022597SimulTRAC-SNB Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022603SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022542SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2016-10-20
14560189211916AIA-PACK FolateTOSOH CORPORATIONCGN2016-09-24
14560189212005AIA-PACK RBC FOLATETOSOH CORPORATIONCGN2016-09-24
04560189211926AIA-PACK Folate Calibrator SetTOSOH CORPORATIONCGN2016-09-24
04560189211933AIA-PACK Folate Pretreatment SetTOSOH CORPORATIONCGN2016-09-24
04560189211940AIA-PACK Floate Sample Diluting SolutionTOSOH CORPORATIONCGN2016-09-24
04560189212015AIA-PACK RBC FOLATE CALIBRATOR SETTOSOH CORPORATIONCGN2016-09-24
04560189212022AIA-PACK RBC FOLATE HEMOLYZING REAGENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212039AIA-PACK RBC FOLATE PRETREATMENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212046AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONCGN2016-09-24
00842768016653Dimension Vista® Flex® reagent cartridge FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414204192ADVIA Centaur® FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24