Home GUDID 00893038002135 Alere Triage®
Primary DI 00893038002135
Brand Alere Triage®
Company Alere San Diego, Inc.
Model 94400
Catalog number 94400
Device description Alere Triage® TOX Drug Screen
Published 2016-09-19
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 DIS Enzyme Immunoassay, Barbiturate DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine JXO Enzyme Immunoassay, Cocaine LAT Radioimmunoassay, Cannabinoid(S) LCM Enzyme Immunoassay, Phencyclidine LDJ Enzyme Immunoassay, Cannabinoids LDP Colorimetry, Acetaminophen MLK Thin Layer Chroomatography, Tricyclic Antidepressant Drugs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIS Enzyme Immunoassay, Barbiturate 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 JXO Enzyme Immunoassay, Cocaine Clinical Toxicology 2 LAT Radioimmunoassay, Cannabinoid(S) Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 LDP Colorimetry, Acetaminophen Clinical Toxicology 2 MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00893038002135 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 00893038002135 00893038002135 893038002135 0893038002135
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a fluorescent 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 194854949 Device count 1 Kit true Lot or batch true Manufacturing date on label 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# 
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