FDA.reportPublic FDA data

Echinococcus multilocularis (Em2-Em18) IgG ELISA

Primary DI
07640158219300
Brand
Echinococcus multilocularis (Em2-Em18) IgG ELISA
Company
Bordier affinity products S.A.
Model
9300
Catalog number
9300
Device description
The Echinococcus multilocularis (Em2-Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples.
Published
2022-08-09
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
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
07640158219300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158219300076401582193007640158219300

GMDN Terms#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640158219607Schistosoma mansoni IgG ELISA960096002022-08-09
07640158219805Anisakidae IgG ELISA980098002022-10-05
07640158219652Fasciola hepatica IgG ELISA 965096502022-09-30
07640158219256Ascaris IgG ELISA925092502022-09-29
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
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
ENTIECHG01300NovaLisa Echinococcus IgGGold Standard Diagnostics Frankfurt GmbHGPF2024-08-26
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
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