Home GUDID 05391516747745 Trinity Biotech
Primary DI 05391516747745
Brand Trinity Biotech
Company MARDX DIAGNOSTICS, INC.
Model 31-8203
Catalog number 31-8203
Device description FTA-ABS Sorbent, 5.0 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 GMW Test, Sorbent, Fta-Abs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMW Test, Sorbent, Fta-Abs Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391516747745 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391516747745 05391516747745 5391516747745
GMDN Terms# Term, Definition table Term Definition Treponema pallidum antigen IVD, kit, direct fluorescent test (DFT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Treponema pallidum in a clinical specimen using a direct fluorescent test (DFT). The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
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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