FDA.reportPublic FDA data

NovaLisa Echinococcus IgG

Primary DI
ENTIECHG01300
Brand
NovaLisa Echinococcus IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
ECHG0130
Catalog number
ECHG0130
Device description
The Echinococcus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Echinococcus 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
GPFAntigen, Agglutinating, Echinococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GPFAntigen, Agglutinating, Echinococcus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTIECHG01300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Echinococcus granulosus/E. multilocularis 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 Echinococcus granulosus and/or Echinococcus multilocularis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with the parasitic tapeworms associated with hydatid disease.

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
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
ENTITOCG0450NovaLisa Toxocara canis IgGTOCG0450TOCG04502024-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIECHG0130NovaLisa Echinococcus IgGGold Standard Diagnostics Frankfurt GmbHGPF2024-08-26
00894175000138AccuDiag ™Diagnostic Automation, Inc.GPF2024-03-27
08033891320010CHORUS ECHINOCOCCUS IgGDIESSE DIAGNOSTICA SENESE SPAGPF2024-01-22
04048474034721Echinococcus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGPF2023-08-29
00840239034724Echinococcus IgG ELISADRG International IncGPF2023-08-24
B350GSD0130030Echinococcus IgG ELISA Test KitGold Standard Diagnostics CorporationGPF2022-12-07
07640158219317Echinococcus multilocularis (Em18) IgG ELISA Bordier affinity products S.A.GPF2022-08-17
07640158219300Echinococcus multilocularis (Em2-Em18) IgG ELISA Bordier affinity products S.A.GPF2022-08-09
07640158219355Echinococcus granulosus IgG ELISABordier affinity products S.A.GPF2022-08-09
00404847434729Echinococcus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGPF2021-06-07
B24220EGGHUE010Echinococcus Granulosus IgG ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.GPF2020-09-25