Home GUDID 05055273202137 DOA
Primary DI 05055273202137
Brand DOA
Company RANDOX LABORATORIES LIMITED
Model EV3500
Catalog number EV3500
Device description The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays.
Published 2016-09-24
Public version status Update
Distribution status 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 DIS Enzyme Immunoassay, Barbiturate DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine LCM Enzyme Immunoassay, Phencyclidine 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 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 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055273202137 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055273202137 05055273202137 5055273202137
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, multiplex 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 multiplex 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 227530649 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 05055273220780 BIOHACKER Premium Home Blood Sampling Collection Kit SCK10754 SCK10754 2026-05-22 05055273220797 MALE HORMONE Premium Home Blood Sampling Collection Kit SCK10755 SCK10755 2026-05-22 05055273220803 BASELINE Venous Sample Collection kit SCK10756 SCK10756 2026-05-22 05055273220995 FEMALE HORMONE Premium Home Blood Sampling Collection Kit SCK10767 SCK10767 2026-05-22 05055273221640 BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit SCK10796 SCK10796 2026-05-22 05055273207620 COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) CG5021 2019-06-03 05055273207637 COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) CG5022 2019-06-03 05055273207644 COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) CG5023 2019-06-03 05055273208405 COAGULATION CALIBRATOR (COAG CAL) CG5037 2019-06-03 05055273204476 APOLIPOPROTEIN E (APO E) LP3864 2019-06-03 05055273200034 ALB AB3800 AB3800 2016-09-16 05055273200041 ALB AB362 AB362 2016-09-16 05055273200058 ALB AB3800 AB3800 2016-09-16 05055273208115 ALB AB8301 AB8301 2016-09-16 05055273218985 ConcizuTrace™ ELISA CZM10591 CZM10591 2025-05-30 05055273203400 GLUTATHIONE REDUCTASE (GLUT RED) GR2368 2019-06-03 05055273203417 GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL) GR2608 2019-06-03 05055273203424 GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) GR2609 2019-06-03 05055273205091 RABS RP3857 RP3857 2016-09-26 05055273205893 RX daytona RX3900 RX3900 2018-06-07
Other Devices Sharing Product Codes# 
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