Home GUDID 00868754000208
Coastline Explorer Cup
Primary DI 00868754000208
Brand Coastline Explorer Cup
Company COASTLINE MEDICAL MANAGEMENT, LLC
Model X13-DT13A
Catalog number X13-DT13A
Device description THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr,Ni,pH,Bl,S.G. drugs of abuse test cup
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Single use true
Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJC Thin Layer Chromatography, Methamphetamine DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine LDJ Enzyme Immunoassay, Cannabinoids LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2 DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology 2 DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DJR Enzyme Immunoassay, Methadone Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2 LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00868754000208 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 00868754000208 00868754000208 868754000208 0868754000208
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 Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 079629844 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices Sharing Product Codes#