Home GUDID 00816555020390
ToxCup Drug Screen Cup
Primary DI 00816555020390
Brand ToxCup Drug Screen Cup
Company AMEDITECH INC.
Model HT23
Catalog number HT23
Device description ToxCup® Drug Screen Cup (AMP300/COC300/MET500/OPI300/THC50/MDMA500/MTD300)
Published 2018-10-08
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine LDJ Enzyme Immunoassay, Cannabinoids
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DJR Enzyme Immunoassay, Methadone Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816555020390 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 00816555020390 00816555020390 816555020390 0816555020390
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 one or 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 010551716 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816565020366 KNOWme™ 88433 88433 2023-05-01 00816565020373 KNOWme™ 88453 88453 2023-05-01 00816565020380 KNOWme™ 88431 88431 2023-05-01 00816565021530 eCUP + Drug Screening Device 94615 94615 2020-03-17 00816565021547 eREADER+ Drug Screening Instrument 55161 2020-03-05 00816565020007 ImmuTest Drugs of Abuse Screen Card IMD-AMP IMD-AMP 2016-09-01 00816565020014 ImmuTest Drugs of Abuse Screen Card IMD-BAR IMD-BAR 2016-09-01 00816565020021 ImmuTest Drugs of Abuse Screen Card IMD-BZO IMD-BZO 2016-09-01 00816565020038 ImmuTest Drugs of Abuse Screen Card IMD-COC IMD-COC 2016-09-01 00816565020045 ImmuTest Drugs of Abuse Screen Card IMD-MET IMD-MET 2016-09-01 00816565020052 ImmuTest Drugs of Abuse Screen Card IMD-OPI300 IMD-OPI300 2016-09-01 00816565020069 ImmuTest Drugs of Abuse Screen Card IMD-THC IMD-THC 2016-09-01 00816565020076 ImmuTest Drugs of Abuse Screen Card IMD-12MO3 IMD-12MO3 2016-09-01 00816565020083 ImmuTest Drugs of Abuse Screen Card IMD-8MT IMD-8MT 2016-09-01 00816565020090 ImmuTest Drugs of Abuse Screen Card IMD-5BO300 IMD-5BO300 2016-09-01 00816565020106 ImmuTest Drugs of Abuse Screen Card IMDA-3M IMDA-3M 2016-09-01 00816565020113 ImmuTest Drugs of Abuse Screen Card IMDA-5M IMDA-5M 2016-09-01 00816565020120 ImmuTest Drugs of Abuse Cup IMC-3P IMC-3P 2016-09-01 00816565020137 ImmuTest Drugs of Abuse Cup IMC-5BO3 IMC-5BO3 2016-09-01 00816565020144 ImmuTest Drugs of Abuse Cup IMC-5M IMC-5M 2016-09-01
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