FDA.reportPublic FDA data

Echinococcus multilocularis (Em18) IgG ELISA

Primary DI
07640158219317
Brand
Echinococcus multilocularis (Em18) IgG ELISA
Company
Bordier affinity products S.A.
Model
9310
Catalog number
9310
Device description
The Echinococcus multilocularis (Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples.This test is intended for post-operative and/or post-therapeutic follow-up of infected patients.
Published
2022-08-17
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
07640158219317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158219317076401582193177640158219317

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

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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
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
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
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