Discover

GUDID 06936983144858

Fentanyl Rapid Test Cassette, 25T, 1ng/ml, FDA CLIA WAIVED

Hangzhou AllTest Biotech Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 06936983144858
• NIH Device Record Key: 3dff8ee2-3e70-4e4a-9b00-8c830a128282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discover
• Version Model Number: DISP-CLIAFEN$
• 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	06936983144858 [Unit of Use]
GS1	16936983144855 [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 [Discover]

• 06936983144858: Fentanyl Rapid Test Cassette, 25T, 1ng/ml, FDA CLIA WAIVED
• 06936983144674: Multi-Drug 14 Drugs Rapid Test Cup(Urine), 25T, FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP2
• 06936983144667: Multi-Drug 6 Drugs Rapid Test Cup(Urine), 25T, FDA,CLIA waived, MOP(OPI)300/PCP25/THC50/AMP500/M