CLUNGENE

GUDID 06950921302223

Hangzhou Clongene Biotech Co., Ltd.

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 06950921302223
• NIH Device Record Key: ba8f152e-0d88-4cca-a6c7-0d4b8e4223cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLUNGENE
• Version Model Number: WLH1001-210132
• Company DUNS: 724157438
• Company Name: Hangzhou Clongene Biotech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	06950921302223 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), 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