FDA.reportPublic FDA data

ReQuest

Primary DI
00850487007098
Brand
ReQuest
Company
QUEST INTERNATIONAL, INC.
Model
MUMPS G
Catalog number
Q01-200
Device description
Mumps virus 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
LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJYEnzyme Linked Immunoabsorbent Assay, Mumps VirusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850487007098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007098008504870070988504870070980850487007098

GMDN Terms#

Term, Definition table
TermDefinition
Mumps virus 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 Mumps virus 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
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
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
ENTIMUMG03400NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
ENTIMUMG0340NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
00840239038470Mumps IgM ELISADRG International IncLJY2024-08-20
04048474038477Mumps IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2024-08-20
08033891322458CHORUS MUMPS IgGDIESSE DIAGNOSTICA SENESE SPALJY2024-01-22
00847865010771Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJY2023-01-04
00894175000060AccuDiag ™ Diagnostic Automation, Inc.LJY2021-08-10
B3507205400Gold Standard Diagnostics Is-Mumps IgG ELISA Test KitGold Standard Diagnostics CorporationLJY2020-07-27
05391516743600Trinity BiotechCLARK LABORATORIES, INC.LJY2019-10-25
03573026064525VIDAS® Mumps IgGBIOMERIEUX SALJY2019-09-16
04048474038460Mumps Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2019-06-05
00404847438468Mumps Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2019-06-05
00840239038463Mumps Virus IgG ELISADRG International IncLJY2019-03-20
05391516747110Trinity BiotechCLARK LABORATORIES, INC.LJY2017-05-07
04049016028017Anti-Mumps Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016028024Anti-Mumps Virus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016083283Anti-Mumps Virus AT ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016103646Anti-Mumps Virus ELISA (G5) (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
05391516743617Trinity BiotechCLARK LABORATORIES, INC.LJY2016-09-23
05391516743624Trinity BiotechCLARK LABORATORIES, INC.LJY2016-09-23
00817273020310DiamedixDIAMEDIX CORPORATIONLJY2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12