VIDAS 3

GUDID 03573026613839

VIDAS 3 V1.3.2 PATCH

BIOMERIEUX SA

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 03573026613839
• NIH Device Record Key: b5d9781b-d1e5-4a88-8a3d-f18b9fdf0e72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS 3
• Version Model Number: 1.3.2
• 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	03573026613839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141133

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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: 2020-02-24
• Device Publish Date: 2020-02-14

On-Brand Devices [VIDAS 3]

• 03573026613839: VIDAS 3 V1.3.2 PATCH
• 03573026608866: VIDAS 3 V1.3 DVD SW UPDATE