Home GUDID 05391516747752 Trinity Biotech
Primary DI 05391516747752
Brand Trinity Biotech
Company MARDX DIAGNOSTICS, INC.
Model 31-1503
Catalog number 31-1503
Device description FTA-ABS Conjugate (rodent), 3.0 mL
Published 2016-09-19
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 GMX Antisera, Fluorescent Antibody For Fta-Abs Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMX Antisera, Fluorescent Antibody For Fta-Abs Test Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391516747752 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391516747752 05391516747752 5391516747752
GMDN Terms# Term, Definition table Term Definition Treponema pallidum total antibody IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum bacteria in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 154281349 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# 
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