FDA.reportPublic FDA data

Trichinella spiralis IgG ELISA

Primary DI
07640158219751
Brand
Trichinella spiralis IgG ELISA
Company
Bordier affinity products S.A.
Model
9750
Catalog number
9750
Device description
The Trichinella spiralis ELISA test is a qualitative enzyme immunoassay for the detection of Trichinella spiralis 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
MDTElisa, Trichinella Spiralis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDTElisa, Trichinella SpiralisMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640158219751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158219751076401582197517640158219751

GMDN Terms#

Term, Definition table
TermDefinition
Trichinella spiralis 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 parasitic nematode Trichinella spiralis 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

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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
B379STNG11Strongy DetectTM IgG ELISAINBIOS INTERNATIONAL, INCMDT2024-09-13
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ENTITRIG04800NovaLisa Trichinella spiralis IgGGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
ENTISTRO0690NovaLisa StrongyloidesGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
ENTITRIG0480NovaLisa Trichinella spiralis IgGGold Standard Diagnostics Frankfurt GmbHMDT2024-08-27
00894175000626AccuDiag ™Diagnostic Automation, Inc.MDT2024-03-06
00894175000831AccuDiag ™Diagnostic Automation, Inc.MDT2024-03-06
04048474058543Ascaris IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-09-02
04048474038668Trichinella spiralis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-08-31
04048474042085Strongyloides IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-08-31
04048474035216Trichinella spiralis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMDT2023-08-29
00840239038661Trichinella spiralis IgG ELISADRG International IncMDT2023-08-25
04049016131601Anti-Strongyloides ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMDT2022-12-08
B350GSD0130120Strongyloides IgG ELISA Test KitGold Standard Diagnostics CorporationMDT2022-11-25
B350GSD0130020Trichinella spiralis IgG ELISA Test KitGold Standard Diagnostics CorporationMDT2022-10-14
07640158219256Ascaris IgG ELISABordier affinity products S.A.MDT2022-09-29
07640158219454Strongyloides ratti IgG ELISABordier affinity products S.A.MDT2022-08-08
00894175000121AccuDiag ™ Diagnostic Automation, Inc.MDT2021-08-23
00840239035219Trichinella spiralis IgG ELISADRG International IncMDT2021-06-07
00840239042088Strongyloides IgG ELISADRG International IncMDT2021-06-07
00840239058546Ascaris IgG ELISADRG International IncMDT2021-06-07