Home GUDID 05391516745673 Trinity Biotech
Primary DI 05391516745673
Brand Trinity Biotech
Company MARDX DIAGNOSTICS, INC.
Model 31-8100
Catalog number 31-8100
Device description FTA-ABS Test System (Treponema pallidum Antibody Test System, 100 Tests)
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 GMS Anti-Human Globulin, Fta-Abs Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMS Anti-Human Globulin, Fta-Abs Test Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391516745673 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391516745673 05391516745673 5391516745673
GMDN Terms# Term, Definition table Term Definition Treponema pallidum antigen IVD, kit, fluorescent immunoassay 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 fluorescent immunoassay method. 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 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 00850054026798 QMedix™ Diagnostic Automation, Inc. GMS 2024-11-14 00894175000008 AccuDiag ™ Diagnostic Automation, Inc. GMS 2021-08-06 05391516747912 Trinity Biotech MARDX DIAGNOSTICS, INC. GMS 2016-09-19
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