FDA.reportPublic FDA data

CHORUS MUMPS IgG

Primary DI
08033891322458
Brand
CHORUS MUMPS IgG
Company
DIESSE DIAGNOSTICA SENESE SPA
Model
81075
Catalog number
81075
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
08033891322458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033891322458080338913224588033891322458

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435036669
Device count
1
Premarket exempt
true
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
08033891322571CHORUS CLEANING SOLUTION 200083609836092026-03-23
08033891322588ENZY-WELL/CHORUS WASHING BUFFER83606836062026-03-23
08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENT83607836072026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFER82050820502026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTION82052820522026-03-23
08033891323103CHORUS WASHING BUFFER AUTOIMMUNITY86004860042026-03-23
08033891328849CHORUS SANITIZING SOLUTION83604836042026-03-23
08033891322748CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH82306823062025-08-19
08033891322779CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS82308823082025-08-19
08033891322670CHORUS EVO82000820002025-07-01
08033891322786CHORUS FECAL ELASTASE86114861142025-07-01
08033891328474CHORUS CLIA FECAL ELASTASE82304823042025-07-01
08033891328481CHORUS ELASTASE COPROCOLLECT86116861162025-07-01
08033891320010CHORUS ECHINOCOCCUS IgG81284812842024-01-22
08033891320522VACU-TEC10200102002024-01-22
08033891320645VACU-TEC CUVETTE-L10208102082024-01-22
08033891320690VES-TEC CUVETTE-L10214102142024-01-22
08033891321086VACU-TEC S.C.10600106002024-01-22
08033891321093VACU-TEC S.C. STERILE10602106022024-01-22
08033891322083CHORUS Q FEVER PHASE II IgG81171811712024-01-22

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
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
00850487007081ReQuest QUEST INTERNATIONAL, INC.LJY2016-08-31