FDA.reportPublic FDA data

ReQuest

Primary DI
00850487007180
Brand
ReQuest
Company
QUEST INTERNATIONAL, INC.
Model
EB VCA G
Catalog number
Q01-470
Device description
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) 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
LSEEpstein-Barr Virus, Other

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSEEpstein-Barr Virus, OtherMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850487007180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007180008504870071808504870071800850487007180

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) immunoglobulin G (IgG) 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 G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

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
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
00850487007029ReQuest TOXO MQ01-1302016-08-31
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
04048474027945Epstein Barr Virus VCA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSE2023-08-29
04048474027969EBV-EA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSE2023-08-29
00840239027948Epstein Barr Virus VCA IgM ELISADRG International IncLSE2023-08-24
00840239027962EBV-EA IgG ELISADRG International IncLSE2023-08-24
00847865011167Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-22
03610522051243Bio-RadBio-RAD Laboratories, Inc.LSE2023-01-21
00847865010788Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-04
00847865010795Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-04
B3507206000Gold Standard Diagnostics Is-EBV-VCA IgG Test KitGold Standard Diagnostics CorporationLSE2022-12-07
B3507206100Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics CorporationLSE2022-12-07
B3507206500Gold Standard Diagnostics Is-EBV-EA-D IgM Test KitGold Standard Diagnostics CorporationLSE2022-12-07
00840733103247MERIFLUOR EBV-EA IgG IFAMERIDIAN BIOSCIENCE, INC.LSE2020-12-09
B3507206300Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test KitGold Standard Diagnostics CorporationLSE2020-07-27
05391516746564Bio-Rad PlateliaCLARK LABORATORIES, INC.LSE2019-11-14
05391516746540Bio-Rad PlateliaCLARK LABORATORIES, INC.LSE2019-11-07
05391516743365Trinity BiotechCLARK LABORATORIES, INC.LSE2019-11-05
05391516746953Trinity BiotechCLARK LABORATORIES, INC.LSE2019-11-05
05391516743334Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516743556Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516746946Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516747080Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516747196PlateliaCLARK LABORATORIES, INC.LSE2019-08-06
00817273020327DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020334DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020341DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020365DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00813545025595EBV-EA IgG 120 Test Kit SCIMEDX CORPORATIONLSE2016-09-20
00813545025618EBV EA 10 Well; 10 pk SCIMEDX CORPORATIONLSE2016-09-20
00847865000161BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12
00847865002127BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12