FDA.reportPublic FDA data

NovaLisa Parainfluenza Virus 1, 2, 3 IgG

Primary DI
ENTIPAIG03600
Brand
NovaLisa Parainfluenza Virus 1, 2, 3 IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
PAIG0360
Catalog number
PAIG0360
Device description
The Parainfluenza Virus 1, 2, 3 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Parainfluenza Virus 1, 2, 3 in human serum or plasma (citrate, heparin).
Published
2024-08-27
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
GQPAntisera, Neutralization, Parainfluenza Virus 1-4

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQPAntisera, Neutralization, Parainfluenza Virus 1-4Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTIPAIG03600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple human parainfluenza 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 one or multiple strains of human parainfluenza 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
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
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
ENTITOCG0450NovaLisa Toxocara canis IgGTOCG0450TOCG04502024-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIPAIG0360NovaLisa Parainfluenza Virus 1, 2, 3 IgGGold Standard Diagnostics Frankfurt GmbHGQP2024-08-27