EXPLORO Highly Sensitive NICOTINE URINE TEST COT200NGML

GUDID 06974246460994

Safecare Biotech (Hangzhou) Co., Ltd.

Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 06974246460994
• NIH Device Record Key: 288de577-c8cc-494d-a5bf-2db3c3e10690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPLORO Highly Sensitive NICOTINE URINE TEST
• Version Model Number: 15 tests
• Catalog Number: COT200NGML
• Company DUNS: 544349634
• Company Name: Safecare Biotech (Hangzhou) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974246460994 [Primary]

FDA Product Code

• MRS: Test System, Nicotine, Cotinine, Metabolites

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 NICOTINE URINE TEST]

• 06974246461014: 25 tests
• 06974246461007: 20 tests
• 06974246460994: 15 tests
• 06974246460987: 5 tests