FDA.reportPublic FDA data

ReQuest

Primary DI
00850487007029
Brand
ReQuest
Company
QUEST INTERNATIONAL, INC.
Model
TOXO M
Catalog number
Q01-130
Device description
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00850487007029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007029008504870070298504870070290850487007029

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
883350811
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
00850487007302ReQuest ANA ScreenQ01-310H2016-08-31
00850487007425SeraQuest ANA ScreenQ01-310H2016-08-31
00850487007234ReQuest Anti-TPO2016-08-31
00850487007500SeraQuest Anti-TPO2016-08-31
00850487007173ReQuest EB VCA MQ01-4802016-08-31
00850487007180ReQuestEB VCA GQ01-4702016-08-31
00850487007371SeraQuest EB VCA GQ01-4702016-08-31
00850487007418SeraQuest EB VCA MQ01-4802016-08-31
00850487007005ReQuest Anti-SSAQ01-2502016-08-31
00850487007012ReQuestVZV GQ01-1802016-08-31
00850487007036ReQuest TOXO GQ01-1202016-08-31
00850487007043ReQuest Syphilis GQ01-5802016-08-31
00850487007050ReQuest Sm/RNPQ01-2402016-08-31
00850487007067ReQuest RUB MQ01-1102016-08-31
00850487007074ReQuest RUB GQ01-1002016-08-31
00850487007081ReQuest Mumps MQ01-200M2016-08-31
00850487007098ReQuest MUMPS GQ01-2002016-08-31
00850487007104ReQuest MEAS MQ01-190M2016-08-31
00850487007111ReQuestMEAS GQ01-1902016-08-31
00850487007128ReQuest HSV Type 2 GQ01-4202016-10-31

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