Alltest

GUDID 06936983143448

25T,white package, FDA, RX,1ng

Hangzhou AllTest Biotech Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 06936983143448
• NIH Device Record Key: 9fc57334-443e-41a3-b801-834fd942a51d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alltest
• Version Model Number: 121151-1-44
• 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	06936983143448 [Unit of Use]
GS1	16936983143445 [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: 2023-11-28
• Device Publish Date: 2023-11-20

On-Brand Devices [Alltest ]

• 06936983143448: 25T,white package, FDA, RX,1ng
• 06936983144650: Fentanyl Urine Test Cassette, 1T*6,FDA, OTC,1ng
• 06936983144551: AllTest Fentanyl Urine Test Cassette, 25T (for FDA Clia Waived)1ng, White pouch
• 06936983143370: Fentanyl Urine Test Cassette, 25T,FDA clia waived,1ng
• 06936983143950: Fentanyl Urine Test Cassette, 1T,FDA, OTC,1ng