Home GUDID 00380740117221 Alinity
Primary DI 00380740117221
Brand Alinity
Company Abbott GmbH & Co. KG
Model 06P0850
Catalog number 06P0850
Device description Alinity s Chagas Reagent Kit
Published 2019-10-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740117221 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 00380740117221 00380740117221 380740117221 0380740117221
GMDN Terms# Term, Definition table Term Definition Trypanosoma cruzi total antibody IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the parasitic protozoan Trypanosoma cruzi in a clinical specimen, using a chemiluminescent immunoassay method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 315786293 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 
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