FDA.reportPublic FDA data

Fasciola hepatica IgG ELISA

Primary DI
07640158219652
Brand
Fasciola hepatica IgG ELISA
Company
Bordier affinity products S.A.
Model
9650
Catalog number
9650
Device description
The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of Fasciola hepatica antibodies in human serum samples.
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
07640158219652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158219652076401582196527640158219652

GMDN Terms#

Term, Definition table
TermDefinition
Fasciola hepatica total 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 total antibodies to the parasitic flatworm Fasciola hepatica in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius37 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41216333167cb@bordier.ch

Regulatory Flags#

DUNS number
487811143
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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07640158219201Toxocara canis IgG ELISA920092002022-09-28
07640158219409Acanthocheilonema viteae IgG ELISA940094002022-09-28
07640158219751Trichinella spiralis IgG ELISA975097502022-09-28
07640158216101Aspergillus fumigatus IgG ELISA610061002022-09-21
07640158219706Taenia solium IgG ELISA 970097002022-09-21
07640158219317Echinococcus multilocularis (Em18) IgG ELISA 931093102022-08-17
07640158219300Echinococcus multilocularis (Em2-Em18) IgG ELISA 930093002022-08-09
07640158219355Echinococcus granulosus IgG ELISA935093502022-08-09
07640158219553Entamoeba histolytica IgG ELISA 955095502022-08-09
07640158219454Strongyloides ratti IgG ELISA945094502022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIENTG01400NovaLisa Entamoeba histolytica IgGGold Standard Diagnostics Frankfurt GmbHKHW2024-08-26
ENTIENTG0140NovaLisa 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
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