Device
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, P...
Manufacturer
Hangzhou Laihe Biotech Co.,Ltd.
Hangzhou Laihe Biotech Co.,Ltd.
Model: DOA-765
Catalog: DOA-765
DI: 06972412618897
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Distribution End: 2050-05-06
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6ea1f7fd-26bc-4d00-9962-11134c96aefb
Distribution Status:
In Commercial Distribution
DUNS Number:
543330912
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
06972412618897
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46994
Name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Definition:
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.
FDA Product Codes
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
Premarket Submissions
Submission Number:
K240287
Supplement Number:
000