Lyher

GUDID 06972412611966

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.

Hangzhou Laihe Biotech Co.,Ltd.

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 06972412611966
• NIH Device Record Key: 73721d40-5717-47b1-bd39-bfe645aef777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lyher
• Version Model Number: DTH-101
• Company DUNS: 543330912
• Company Name: Hangzhou Laihe Biotech Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972412611966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232604

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

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