FDA.reportPublic FDA data

NovaLisa Respiratory Syncytial Virus IgG

Primary DI
ENTIRSVG03800
Brand
NovaLisa Respiratory Syncytial Virus IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
RSVG0380
Catalog number
RSVG0380
Device description
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin).
Published
2024-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCERespiratory Syncytial Virus - Elisa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCERespiratory Syncytial Virus - ElisaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTIRSVG03800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) 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 respiratory syncytial virus (RSV) 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
ENTITOCG0450NovaLisa Toxocara canis IgGTOCG0450TOCG04502024-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIRSVG0380NovaLisa Respiratory Syncytial Virus IgGGold Standard Diagnostics Frankfurt GmbHMCE2024-08-26
04048474035070RSV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMCE2023-08-29
00840239035073RSV IgG ELISA DRG International IncMCE2023-08-24
00404847435078RSV IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMCE2021-06-07
30014613201939QuickVueQUIDEL CORPORATIONMCE2018-11-10
04049016028222Anti-RSV ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGMCE2016-09-24
04049016028239Anti-RSV ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMCE2016-09-24
04049016028246Anti-RSV ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGMCE2016-09-24