FDA.reportPublic FDA data

Access Toxo IgM II QC

Primary DI
15099590624781
Brand
Access Toxo IgM II QC
Company
Beckman Coulter, Inc.
Model
34479
Catalog number
34479
Device description
The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II assay.
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
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590624781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959062478115099590624781

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
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
00380740189976AlinityAbbott GmbHLGD2025-04-08
00380740190002AlinityAbbott GmbHLGD2025-04-08
00380740200626AlinityAbbott GmbHLGD2025-04-08
00380740200633AlinityAbbott GmbHLGD2025-04-08
00816870024080Toxo IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LGD2024-09-13
00816870024097Toxo IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LGD2024-09-13
00816870024127Toxo IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LGD2024-09-13
00816870024134Toxo IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LGD2024-09-13
07613336218464Elecsys Toxo IgMRoche Diagnostics GmbHLGD2024-08-13
00850054026002QMedix™Diagnostic Automation, Inc.LGD2024-02-02
00850049545662AccuDiag ™Diagnostic Automation, Inc.LGD2023-06-14
B3507203000Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test KitGold Standard Diagnostics CorporationLGD2022-12-05
00380740174354AlinityAbbott GmbHLGD2022-11-26
00380740174361AlinityAbbott GmbHLGD2022-11-26
00380740203177AlinityAbbott GmbHLGD2022-11-26
05391516746823Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
05391516747479Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
00630414600123Atellica IM Toxo GSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600130Atellica IM Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600147Atellica IM Toxo MSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600154Atellica IM Toxo M QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
04015630921485Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
04015630940318Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
04015630940301Elecsys Toxo IgGRoche Diagnostics GmbHLGD2017-04-21
00630414208442ADVIA Centaur® Toxo MSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208459ADVIA Centaur® Toxo GSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208756ADVIA Centaur® Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2016-09-24