AllTest

GUDID 06936983144551

AllTest Fentanyl Urine Test Cassette, 25T (for FDA Clia Waived)1ng, White pouch

Hangzhou AllTest Biotech Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 06936983144551
• NIH Device Record Key: e281e195-eb61-41c5-bf22-a70af8eebd5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AllTest
• Version Model Number: DFY-A102C (1ng)
• 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	06936983144551 [Unit of Use]
GS1	06936983144568 [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

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