CLIA waived,Inc. Rapid Drug Test Device “RDTD” for Fentanyl in Urine

GUDID 06936983144643

25T,FDA clia waived,1ng

Hangzhou AllTest Biotech Co., Ltd.

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• Primary Device ID: 06936983144643
• NIH Device Record Key: 6d770018-c531-4447-8d13-c1d76f3b76a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLIA waived,Inc. Rapid Drug Test Device “RDTD” for Fentanyl in Urine
• Version Model Number: DFY-A102C
• 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: 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	06936983144643 [Unit of Use]
GS1	16936983144640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233417

FDA Product Code

• NGL: Test, Opiates, 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: 2023-12-08
• Device Publish Date: 2023-11-30

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

• 06936983148504 - Discover Fentanyl Rapid Tes Cassette: 2024-02-16 1T, cut-off:1ng/ml,FDA OTC
• 06936983149310 - 2SAN Fentanyl Rapid Tes Cassette: 2024-02-16 1T,FDA, OTC,1ng
• 06936983149426 - Identify Fentanyl Rapid Cassette: 2024-02-16 1T,EN,FDA, OTC,1ng
• 06936983149433 - Identify Fentanyl Rapid Cassette: 2024-02-16 25T,EN,FDA clia waived,1ng
• 16936983150634 - Discover milti-drug 8 drugs rapid test cup (urine): 2024-02-16 1T,MOP(OPI)300/OXY100/COC150/MET500/BAR300/BZO300/AMP500/BUP10+CRE/SG/PH,FDA clia waived
• 06936983143950 - Alltest: 2023-12-08 Fentanyl Urine Test Cassette, 1T,FDA, OTC,1ng
• 06936983143370 - Alltest: 2023-12-08 Fentanyl Urine Test Cassette, 25T,FDA clia waived,1ng
• 06936983144551 - AllTest: 2023-12-08 AllTest Fentanyl Urine Test Cassette, 25T (for FDA Clia Waived)1ng, White pouch