FDA.reportPublic FDA data

NovaLisa Entamoeba histolytica IgG

Primary DI
ENTIENTG0140
Brand
NovaLisa Entamoeba histolytica IgG
Company
Gold Standard Diagnostics Frankfurt GmbH
Model
ENTG0140
Catalog number
ENTG0140
Device description
The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica 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
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENTIENTG0140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Entamoeba histolytica 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 Entamoeba histolytica in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIENTG01400NovaLisa Entamoeba histolytica IgGGold Standard Diagnostics Frankfurt GmbHKHW2024-08-26
00894175000282AccuDiag ™Diagnostic Automation, Inc.KHW2024-03-06
04048474038309Entamoeba histolytica IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungKHW2023-08-31
04048474034745Entamoeba histolytica IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungKHW2023-08-29
00840239038302Entamoeba histolytica IgG ELISADRG International IncKHW2023-08-25
B350GSD0130130Entamoeba histolytica IgG ELISA Test KitGold Standard Diagnostics CorporationKHW2022-11-18
07640158219652Fasciola hepatica IgG ELISA Bordier affinity products S.A.KHW2022-09-30
07640158219553Entamoeba histolytica IgG ELISA Bordier affinity products S.A.KHW2022-08-09
00083059070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.KHW2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.KHW2019-05-31
00840239034748E. Histolytica IgG ELISADRG International IncKHW2019-03-20
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.KHW2017-10-05
00857031002202E. HISTOLYTICA QUIK CHEKTECHLAB, INC.KHW2017-09-15
08305900070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.KHW2016-12-08
00857031002011E. HISTOLYTICA IITECHLAB, INC.KHW2016-08-23
00857031002349E. HISTOLYTICA IITECHLAB, INC.KHW2016-08-23