Discover milti-drug 8 drugs rapid test cup (urine) DISP-DUD484N$

GUDID 16936983150634

1T,MOP(OPI)300/OXY100/COC150/MET500/BAR300/BZO300/AMP500/BUP10+CRE/SG/PH,FDA clia waived

Hangzhou AllTest Biotech Co., Ltd.

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• Primary Device ID: 16936983150634
• NIH Device Record Key: 730b6632-607c-48e3-95c3-296f6954385b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discover milti-drug 8 drugs rapid test cup (urine)
• Version Model Number: DUA-A187C-A3 A1617
• Catalog Number: DISP-DUD484N$
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	16936983150634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182738

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: 2024-02-16
• Device Publish Date: 2024-02-08

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