FirstCheck HOME DRUG TEST

GUDID 06936983177689

REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50

Hangzhou AllTest Biotech Co., Ltd.

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

• Primary Device ID: 06936983177689
• NIH Device Record Key: c495274a-2e98-415a-8293-df46b0da9384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FirstCheck HOME DRUG TEST
• Version Model Number: 1
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936983177689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K244043

FDA Product Code

• NGG: Test, Methamphetamine, 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: 2025-02-24
• Device Publish Date: 2025-02-14

On-Brand Devices [FirstCheck HOME DRUG TEST]

• 06936983177689: REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
• 06936983177245: ABTDOAO114701A, 1T/kit, AMP500/BAR300/BUP10/BZO300/COC150/FYL1/MDMA500/MET500/MOP300/MTD300/OXY1
• 06936983177238: ABTDOAO16701A, 1T/kit, AMP500/COC150/FYL1/MET500/MOP300/THC50
• 06936983177221: ABTDTHO11701A, 1T/kit, THC50