Home GUDID 05391516747776 Trinity Biotech
Primary DI 05391516747776
Brand Trinity Biotech
Company MARDX DIAGNOSTICS, INC.
Model 31-8202
Catalog number 31-8202
Device description FTA-ABS Reactive Control, 0.5 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 GMR Sera, Reactive And Non-Specific Control, Fta-Abs Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMR Sera, Reactive And Non-Specific Control, Fta-Abs Test Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391516747776 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391516747776 05391516747776 5391516747776
GMDN Terms# Term, Definition table Term Definition Treponema pallidum total antibody IVD, control A material which is used to verify the performance of an assay intended to be 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05060515140047 PK7400 TP HA CONTROLS NEWMARKET BIOMEDICAL LIMITED GMR 2019-11-14 05391516747769 Trinity Biotech MARDX DIAGNOSTICS, INC. GMR 2016-09-19
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