Fasciola hepatica IgG ELISA 9650

GUDID 07640158219652

The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of Fasciola hepatica antibodies in human serum samples.

Bordier affinity products S.A.

Fasciola hepatica total antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07640158219652
NIH Device Record Key8e182404-e296-45f1-8202-d58dc442ecbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameFasciola hepatica IgG ELISA
Version Model Number9650
Catalog Number9650
Company DUNS487811143
Company NameBordier affinity products S.A.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41216333167
Emailcb@bordier.ch

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640158219652 [Primary]

FDA Product Code

KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-10
Device Publish Date2022-09-30

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