Exploro Highly Sensitive Urine Drug Test (5-Panel) MDP-1054

GUDID 06974246462110

Safecare Biotech (Hangzhou) Co., Ltd.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 06974246462110
• NIH Device Record Key: bb16dc79-e115-4f16-81a8-23d7c1ad37f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exploro Highly Sensitive Urine Drug Test (5-Panel)
• Version Model Number: 7 tests
• Catalog Number: MDP-1054
• 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	06974246462110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201120

FDA Product Code

• NFT: Test, Amphetamine, 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: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [Exploro Highly Sensitive Urine Drug Test (5-Panel)]

• 06974246462141: 2 tests
• 06974246462134: 5 tests
• 06974246462127: 3 tests
• 06974246462110: 7 tests
• 06974246462103: 10 tests