FDA.reportPublic FDA data

Access Thyroglobulin

Primary DI
15099590227173
Brand
Access Thyroglobulin
Company
Beckman Coulter, Inc.
Model
33860
Catalog number
33860
Device description
The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin 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
MSWSystem,Test,Thyroglobulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSWSystem, Test, ThyroglobulinImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590227173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022717315099590227173

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroglobulin 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
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
00630414238418Atellica IM TgSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2025-09-22
00630414238425Atellica IM TgSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2025-09-22
15099590754501Access ThyroglobulinBeckman Coulter, Inc.MSW2023-12-01
07613336169582Elecsys Tg IIRoche Diagnostics GmbHMSW2023-10-31
07613336203569Elecsys Tg IIRoche Diagnostics GmbHMSW2023-10-31
00630414953199IMMULITE® Systems GAS CONTROL GastrinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2020-09-24
00816870021768Tg AccuBind ELISA Test System - 96 WellsMONOBIND, INC.MSW2019-02-11
00816870021775Tg AccuBind ELISA Test System - 192 WellsMONOBIND, INC.MSW2019-02-11
00816870023205Monobind AccuLite Tg CLIA Kit - 96 WellsMONOBIND, INC.MSW2019-02-11
00816870023212Tg AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MSW2019-02-11
00630414954301IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414954318IMMULITE® 2000 Systems TG Thyroglobulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414954523IMMULITE® Systems TG Recovery Sample ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414972077IMMULITE®/IMMULITE® 1000 Systems TG ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414972084IMMULITE® 2000 Systems TG ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414978345IMMULITE® Systems TG CONTROL ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
15099590225858Access Thyroglobulin Sample DiluentBeckman Coulter, Inc.MSW2016-09-09
15099590227166Access Thyroglobulin CalibratorsBeckman Coulter, Inc.MSW2016-09-09
04260157631106B.R.A.H.M.S Tg-pluS RIAB.R.A.H.M.S GmbHMSW2016-08-17