CLUNGENE

GUDID 06950921302377

Hangzhou Clongene Biotech Co., Ltd.

Human chorionic gonadotropin alpha-subunit IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 06950921302377
• NIH Device Record Key: 42e47518-67df-452b-89c1-7023b6afd0f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLUNGENE
• Version Model Number: Strip
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950921302377 [Primary]

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, 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: 2023-09-18
• Device Publish Date: 2023-09-09