EXPLORO Highly Sensitive THC Test THC50NGML

GUDID 06974246460963

Safecare Biotech (Hangzhou) Co., Ltd.

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

• Primary Device ID: 06974246460963
• NIH Device Record Key: 50d4470b-50c3-4fba-ba87-21290e7533e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPLORO Highly Sensitive THC Test
• Version Model Number: 20 tests
• Catalog Number: THC50NGML
• 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	06974246460963 [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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [EXPLORO Highly Sensitive THC Test]

• 06974246460772: THC-1011
• 06974246460949: 3 tests
• 06974246460970: 50 tests
• 06974246460963: 20 tests
• 06974246460956: 5 tests
• 06974246461304: 7 tests