Home GUDID 50096295140588 LEADER
Primary DI 50096295140588
Brand LEADER
Company CARDINAL HEALTH, INC.
Model 5688338
Catalog number 5688338
Device description LDR At-Home Drug Test (12 drugs tested)
Published 2021-06-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name DIJ LEAD, DELTA AMINO LEVULINIC ACID
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIJ Lead, Delta Amino Levulinic Acid Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50096295140588 Package GS1 6 In Commercial Distribution 00096295140583 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 50096295140588 50096295140588 00096295140583 00096295140583 096295140583 0096295140583
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 097537435 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false 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 true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00096295140583 LEADER Cardinal Health 110, Inc. DIJ 2021-06-11
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