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

GUDID 06974246461212

Safecare Biotech (Hangzhou) Co., Ltd.

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

• Primary Device ID: 06974246461212
• NIH Device Record Key: fff9becf-1fa5-4a81-bfd4-a4730b80a0ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exploro Highly Sensitive 5-Panel Urine Drug Test
• Version Model Number: 3 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	06974246461212 [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: 2024-04-01
• Device Publish Date: 2024-03-22

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

• 06974246461243: 10 tests
• 06974246461236: 7 tests
• 06974246461229: 5 tests
• 06974246461212: 3 tests
• 06974246461205: 2 tests