THxID™ BRAF

GUDID 03573026559823

Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

BIOMERIEUX SA

BRAF gene mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03573026559823
• NIH Device Record Key: 5ab497ae-054a-494f-82f5-7bc9dcab444b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THxID™ BRAF
• Version Model Number: 1.0
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026559823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120014

FDA Product Code

• OWD: Somatic Gene Mutation Detection System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-06-09
• Device Publish Date: 2017-05-12

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