Home GUDID 06972412618897 LYHER
Primary DI 06972412618897
Brand LYHER
Company Hangzhou Laihe Biotech Co.,Ltd.
Model DOA-765
Catalog number DOA-765
Device description The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Published 2026-05-06
Public version status New
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 DJC Thin Layer Chromatography, Methamphetamine DJG Enzyme Immunoassay, Opiates DKZ Enzyme Immunoassay, Amphetamine 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 DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine 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 06972412618897 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06972412618897 06972412618897 6972412618897
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, rapid ICT, clinical 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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 543330912 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06937339211507 BioSieve Vivachek Biotech (Hangzhou) Co., Ltd. LCM 2026-10-14 06937339211538 BioSieve Vivachek Biotech (Hangzhou) Co., Ltd. LCM 2026-10-14 06942598249376 One Step® Fentanyl(FYL1) Urine Test Panel Hangzhou AllTest Biotech Co., Ltd. DJG 2026-10-12 00894175000091 QMedix™ Diagnostic Automation, Inc. DJG 2026-09-30 00894175000091 QMedix™ Diagnostic Automation, Inc. LCM 2026-09-30 00894175000091 QMedix™ Diagnostic Automation, Inc. LDJ 2026-09-30 00894175000091 QMedix™ Diagnostic Automation, Inc. DIO 2026-09-30 00810173657556 Healgen Scientific Healgen Scientific Limited Liability Company DJG 2026-09-28 00810173657556 Healgen Scientific Healgen Scientific Limited Liability Company DIO 2026-09-28 00810173657556 Healgen Scientific Healgen Scientific Limited Liability Company LDJ 2026-09-28 00810173657556 Healgen Scientific Healgen Scientific Limited Liability Company DKZ 2026-09-28 00810173657556 Healgen Scientific Healgen Scientific Limited Liability Company LCM 2026-09-28 00810173657686 Healgen Scientific Healgen Scientific Limited Liability Company DIO 2026-09-28 00810173657686 Healgen Scientific Healgen Scientific Limited Liability Company LDJ 2026-09-28 00810173657686 Healgen Scientific Healgen Scientific Limited Liability Company DKZ 2026-09-28 00810173657686 Healgen Scientific Healgen Scientific Limited Liability Company LCM 2026-09-28 00810173657686 Healgen Scientific Healgen Scientific Limited Liability Company DJG 2026-09-28 00810173657693 Healgen Scientific Healgen Scientific Limited Liability Company LCM 2026-09-28 00810173657693 Healgen Scientific Healgen Scientific Limited Liability Company LDJ 2026-09-28 00810173657693 Healgen Scientific Healgen Scientific Limited Liability Company DJG 2026-09-28 00810173657693 Healgen Scientific Healgen Scientific Limited Liability Company DIO 2026-09-28 00810173657693 Healgen Scientific Healgen Scientific Limited Liability Company DKZ 2026-09-28 00810173658102 Healgen Scientific Healgen Scientific Limited Liability Company DKZ 2026-09-28 00810173658102 Healgen Scientific Healgen Scientific Limited Liability Company DJG 2026-09-28 00810173658102 Healgen Scientific Healgen Scientific Limited Liability Company LCM 2026-09-28 00810173658102 Healgen Scientific Healgen Scientific Limited Liability Company DIO 2026-09-28 00810173658102 Healgen Scientific Healgen Scientific Limited Liability Company LDJ 2026-09-28 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. DJG 2026-09-24 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. LCM 2026-09-24 B2986080760 DrugCheck Express Diagnostic Int'l, Inc. LDJ 2026-09-24