Lyher

Basic Information

• Brand Name: Lyher
• Primary DI: 06972412611966
• Version / Model: DTH-101
• Company Name: Hangzhou Laihe Biotech Co.,Ltd.
• Labeler DUNS: 543330912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-12
• Public Version: 1
• Public Version Date: 2024-11-20
• Public Version Status: New
• Public Device Record Key: 73721d40-5717-47b1-bd39-bfe645aef777

Device Description

The Urine Marijuana (THC) Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of THC-COOH in urine at the cut-off concentrations: Marijuana (THC) 50ng/mL. The test provides only a preliminary analytical test result. The test is not intended to be used in monitoring the drug levels. A more specific alternate method must be used in order to confirm the 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. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are obtained.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30519	Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972412611966	GS1

Premarket Submissions

Submission Number	Supplement Number
K232604	000