FDA.reportPublic FDA data

NovaLisa Schistosoma mansoni IgG

Primary DI
ENTISCHG04100
Brand
NovaLisa Schistosoma mansoni IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
SCHG0410
Catalog number
SCHG0410
Device description
The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class antibodies against Schistosoma mansoni 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
GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNHAntigen, Fluorescent Antibody Test, Schistosoma MansoniMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTISCHG04100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Schistosoma mansoni 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 the parasitic flatworm Schistosoma mansoni 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
ENTIRSVG03800NovaLisa Respiratory Syncytial Virus IgGRSVG0380RSVG03802024-08-26
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
ENTISCHG0410NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
00894175000114AccuDiag ™Diagnostic Automation, Inc.GNH2024-03-06
04048474038729Schistosoma mansoni IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-31
04048474035124Schistosoma IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-29
00840239038722Schistosoma mansoni IgG ELISADRG International IncGNH2023-08-25
04049016135449Anti-Schistosoma ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2022-12-08
07640158219607Schistosoma mansoni IgG ELISABordier affinity products S.A.GNH2022-08-09
00840239035127Schistosoma IgG ELISADRG International IncGNH2021-06-07
04049016101727Anti-Schistosoma mansoni IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2016-09-24
00813545026455Schistosoma Antibody 96 Tests SCIMEDX CORPORATIONGNH2016-09-21