Welcheck Marijuana(THC) Urine Test Dipcard THC-1014

GUDID 06974246461755

Safecare Biotech (Hangzhou) Co., Ltd.

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

• Primary Device ID: 06974246461755
• NIH Device Record Key: 85ba6ae6-fcc1-4512-b25e-490c5e858050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welcheck Marijuana(THC) Urine Test Dipcard
• Version Model Number: 15 tests
• Catalog Number: THC-1014
• Company DUNS: 544349634
• Company Name: Safecare Biotech (Hangzhou) 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974246461755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191924

FDA Product Code

• NFW: Test, Cannabinoid, Over The Counter

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: 2024-12-06
• Device Publish Date: 2024-11-28

On-Brand Devices [Welcheck Marijuana(THC) Urine Test Dipcard]

• 06974246461762: 7 tests
• 06974246461755: 15 tests