FDA.reportPublic FDA data

Aspergillus fumigatus IgG ELISA

Primary DI
07640158216101
Brand
Aspergillus fumigatus IgG ELISA
Company
Bordier affinity products S.A.
Model
6100
Catalog number
6100
Device description
The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus 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
JWTAntigen, Cf, Aspergillus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWTAntigen, Cf, Aspergillus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640158216101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158216101076401582161017640158216101

GMDN Terms#

Term, Definition table
TermDefinition
Aspergillus fumigatus 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 the fungus Aspergillus fumigatus 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

Other Devices From This Company#

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
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
04048474061291Aspergillus fumigatus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungJWT2023-09-01
00840239061294Aspergillus fumigatus IgG ELISADRG International IncJWT2023-08-26
10634853000220Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000237Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000244Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000404Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000428Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
00404847425017Aspergillus fumigatus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungJWT2021-06-07
00404847461299Aspergillus fumigatus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungJWT2021-06-07
00816387020001IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020025IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020049IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020056IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020063IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020087IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020100IMMYImmuno-Mycologics, Inc.JWT2016-09-24