Home GUDID 00813545025403 E.histolytica Antibody 96 Test with Calibrator
Primary DI 00813545025403
Brand E.histolytica Antibody 96 Test with Calibrator
Company SCIMEDX CORPORATION
Model EH-96C
Catalog number EH-96C
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813545025403 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813545025403 00813545025403 813545025403 0813545025403
GMDN Terms# Term, Definition table Term Definition Entamoeba histolytica antigen 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 antigens from Entamoeba histolytica in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.
Regulatory Flags# DUNS number 155424708 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00813545025397 E.histolytica Antibody 96Tests SCIMEDX CORPORATION GWD 2016-09-20
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