FDA.reportPublic FDA data

NovaLisa Measles Virus IgG

Primary DI
ENTIMEAG0330
Brand
NovaLisa Measles Virus IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
MEAG0330
Catalog number
MEAG0330
Device description
The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTIMEAG0330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Measles 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 Measles 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

Contacts#

Phone, Email table
PhoneEmail
+1(888)977-4739GSD.TechSupport@us.goldstandarddiagnostics.com

Regulatory Flags#

DUNS number
330328514
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ENTIADVG00100NovaLisa Adenovirus IgGADVG0010ADVG00102024-08-26
ENTIECHG01300NovaLisa Echinococcus IgGECHG0130ECHG01302024-08-26
ENTIENTG01400NovaLisa Entamoeba histolytica IgGENTG0140ENTG01402024-08-26
ENTIINFG02900NovaLisa Influenza Virus A IgGINFG0290INFG02902024-08-26
ENTIINFG03000NovaLisa Influenza Virus B IgGINFG0300INFG03002024-08-26
ENTILEPG06600NovaLisa Leptospira IgGLEPG0660LEPG06602024-08-26
ENTIMEAG03300NovaLisa Measles Virus IgGMEAG0330MEAG03302024-08-26
ENTIMUMG03400NovaLisa Mumps Virus IgGMUMG0340MUMG03402024-08-26
ENTIPAIG03600NovaLisa Parainfluenza Virus 1, 2, 3 IgGPAIG0360PAIG03602024-08-27
ENTIRSVG03800NovaLisa Respiratory Syncytial Virus IgGRSVG0380RSVG03802024-08-26
ENTISCHG04100NovaLisa Schistosoma mansoni IgGSCHG0410SCHG04102024-08-26
ENTISTRO06900NovaLisa StrongyloidesSTRO0690STRO06902024-08-27
ENTITAEG04200NovaLisa Taenia solium IgGTAEG0420TAEG04202024-08-27
ENTITOCG04500NovaLisa Toxocara canis IgGTOCG0450TOCG04502024-08-27
ENTITRIG04800NovaLisa Trichinella spiralis IgGTRIG0480TRIG04802024-08-27
ENTICOX1G0600NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgGCOX1G060COX1G06002024-08-26
ENTICOX2G0600NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgGCOX2G060COX2G06002024-08-26
ENTIPAIG0360NovaLisa Parainfluenza Virus 1, 2, 3 IgGPAIG0360PAIG03602024-08-27
ENTISTRO0690NovaLisa StrongyloidesSTRO0690STRO06902024-08-27
ENTITAEG0420NovaLisa Taenia solium IgGTAEG0420TAEG04202024-08-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2026-05-29
00850054026156QMedix™Diagnostic Automation, Inc.LJB2025-06-05
ENTIMEAG03300NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
08033891322434CHORUS MEASLES IgGDIESSE DIAGNOSTICA SENESE SPALJB2024-01-22
04048474059670Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2023-09-01
00840239059673Measles Virus IgG Avidity ELISADRG International IncLJB2023-08-26
00850049545396AccuDiag ™Diagnostic Automation, Inc.LJB2023-06-14
00847865010764Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJB2023-01-22
00404847459678Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2021-06-07
B3507205200Gold Standard Diagnostics Is-Measles IgG ELISA Test KitGold Standard Diagnostics CorporationLJB2020-05-20
05391516743631Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
05391516747127Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
03573026064532VIDAS® Measles IgGBIOMERIEUX SALJB2019-08-30
04048474038446Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00404847438444Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00840239038449Measles Virus IgG ELISADRG International IncLJB2019-03-20
04049016027973Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
04049016083276Avidity: Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
00817273020303DiamedixDIAMEDIX CORPORATIONLJB2016-09-20
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00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
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00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00850487007104ReQuest QUEST INTERNATIONAL, INC.LJB2016-08-31
00850487007111ReQuestQUEST INTERNATIONAL, INC.LJB2016-08-31