DrugTect Multi-Drug Urine Test Cup

GUDID 06942598201817

DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,BZO300, COC150, EDDP300, FYL1,MDMA500, MET500, MOP300, MTD300,OXY100, PCP25, PPX300, TCA1000, THC50,TRA100) Contents: Test Cups - 25, Package Insert - 1, Security seals - 25. For In Vitro Diagnostic Use Only.

Hangzhou AllTest Biotech Co., Ltd.

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

• Primary Device ID: 06942598201817
• NIH Device Record Key: 678dfb76-8e52-429c-ad3a-6e95b1ab3c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugTect Multi-Drug Urine Test Cup
• Version Model Number: DT-AT18-FLAT-1-AZ25
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Device Count: 25
• 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: false
• 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	06942598201817 [Unit of Use]
GS1	16942598201814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250727

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: 2025-11-24
• Device Publish Date: 2025-11-15

On-Brand Devices [DrugTect Multi-Drug Urine Test Cup]

• 06942598201855: DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,
• 06942598201848: DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,
• 06942598201831: DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,
• 06942598201824: DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,
• 06942598201817: DrugTect ,18 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED (6-MAM10, AMP500, BAR300, BUP10,
• 06942598201800: DrugTect ,18 Panel Multi-Drug Urine Test Cup, OTC (6-MAM10, AMP500, BAR300, BUP10,BZO300, COC150
• 16942598201791: DrugTect ,18 Panel Multi-Drug Urine Test Cup, OTC (6-MAM10, AMP500, BAR300, BUP10,BZO300, COC150