CLUNGENE

GUDID 06950921302070

Hangzhou Clongene Biotech Co., Ltd.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 06950921302070
• NIH Device Record Key: 61a75ad0-340c-4fc0-b610-ec25bcf8b646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLUNGENE
• Version Model Number: DDOA1c07-200307
• Company DUNS: 724157438
• Company Name: Hangzhou Clongene 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950921302070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181790

FDA Product Code

• NGG: Test, Methamphetamine, 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: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [CLUNGENE]

• 06950921302377: Strip
• 06950921302230: WLH1001-210133
• 06950921302223: WLH1001-210132
• 06950921302186: DDOA1504-200318
• 06950921302179: DDOA1504-200317
• 06950921302087: DDOA1c07-200308
• 06950921302070: DDOA1c07-200307