FDA.reportPublic FDA data

Acanthocheilonema viteae IgG ELISA

Primary DI
07640158219409
Brand
Acanthocheilonema viteae IgG ELISA
Company
Bordier affinity products S.A.
Model
9400
Catalog number
9400
Device description
The Acanthocheilonema viteae ELISA test is a qualitative enzyme immunoassay for the detection of Acanthocheilonema viteae antibodies in human serum samples.
Published
2022-09-28
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
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640158219409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158219409076401582194097640158219409

GMDN Terms#

Term, Definition table
TermDefinition
Wuchereria bancrofti 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 Wuchereria bancrofti in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Wuchereria bancrofti, the parasitic nematode associated with filariasis.

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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07640158219355Echinococcus granulosus IgG ELISA935093502022-08-09
07640158219553Entamoeba histolytica IgG ELISA 955095502022-08-09
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