FDA.reportPublic FDA data

Taenia solium IgG ELISA

Primary DI
07640158219706
Brand
Taenia solium IgG ELISA
Company
Bordier affinity products S.A.
Model
9700
Catalog number
9700
Device description
The Taenia solium ELISA test is a qualitative enzyme immunoassay for the detection of Taenia solium antibodies in human serum samples.
Published
2022-09-21
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
MDJReagents, Cysticercosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDJReagents, CysticercosisMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640158219706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158219706076401582197067640158219706

GMDN Terms#

Term, Definition table
TermDefinition
Taenia solium 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 Taenia solium in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Taenia solium, the parasitic tapeworm associated with cysticercosis.

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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07640158219300Echinococcus multilocularis (Em2-Em18) IgG ELISA 930093002022-08-09
07640158219355Echinococcus granulosus IgG ELISA935093502022-08-09
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07640158219454Strongyloides ratti IgG ELISA945094502022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTITAEG04200NovaLisa Taenia solium IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
ENTITOCG04500NovaLisa Toxocara canis IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
ENTITAEG0420NovaLisa Taenia solium IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
ENTITOCG0450NovaLisa Toxocara canis IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
00894175000299AccuDiag ™Diagnostic Automation, Inc.MDJ2024-03-06
04048474035131Taenia Solium IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMDJ2023-08-29
04049016141112Anti-Toxocara ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMDJ2022-12-08
B350GSD0130010Toxocara canis IgG ELISA Test KitGold Standard Diagnostics CorporationMDJ2022-10-14
07640158219201Toxocara canis IgG ELISABordier affinity products S.A.MDJ2022-09-28
00840239035134Taenia Solium IgG ELISADRG International IncMDJ2021-06-07
B350GSD0130000GSD Toxocara canis IgG ELISAGold Standard Diagnostics CorporationMDJ2017-07-12
00813545026509T.solium Antibody 96 Tests SCIMEDX CORPORATIONMDJ2016-09-21