Home GUDID 10815845020925 NA
Primary DI 10815845020925
Brand NA
Company Alere San Diego, Inc.
Model DOA-1364
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 JXN Enzyme Immunoassay, Propoxyphene LCM Enzyme Immunoassay, Phencyclidine 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 JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U 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 10815845020925 Primary GS1 0 00815845020928 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10815845020925 10815845020925 00815845020928 00815845020928 815845020928 0815845020928
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.
Regulatory Flags# DUNS number 194854949 Device count 25 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 00810124272975 CERTUM One Step Multi-Line Drug Screen EZ Split DBO-167-022-a 4565161326 2024-10-10 00810124272982 SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300) DAM-A101-a-Sgl 2023-12-15 00810124272999 SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000) DAM-101-a-Sgl 2023-12-15 00810124273002 SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300) DBA-101-a-Sgl 2023-12-15 00810124273019 SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10) DBU-101-a-Sgl 2023-12-15 00810124273026 SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300) DBZ-101-a-Sgl 2023-12-15 00810124273033 SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150) DCO-U101-a-Sgl 2023-12-15 00810124273040 SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500) DME-U101-a-Sgl 2023-12-15 00810124273057 SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500 DMD-101-a-Sgl 2023-12-15 00810124273064 SureStepTM Urine Test Drug Screen Strip, Opiate (MOP 300) DMO-101-a-Sgl 2023-12-15 00810124273071 SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300) DMT-101-a-Sgl 2023-12-15 00810124273088 SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000) DTC-101-a-Sgl 2023-12-15 00810124273095 SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50) DTH-101-a-Sgl 2023-12-15 00810124273149 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup DBO-157-012 4565339019 2024-09-17 00810124273156 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup DBO-167-521 4565349019 2024-09-17 00810124273163 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup DBO-1107-021 4565359019 2024-09-17 00810124273170 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup DBO-1107-011 4565369019 2024-09-17 00810124273200 SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300) DCO-101-a-Sgl 2023-12-15 00810124273217 SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000) DME-101-a-Sgl 2023-12-15 00810124273224 SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000) DMO-101-a-Sgl 2023-12-15
Other Devices Sharing Product Codes#