VIDAS® 3 SOFTWARE V1.4

GUDID 03573026617622

VIDAS 3 V1.4 Software

BIOMERIEUX SA

Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 03573026617622
• NIH Device Record Key: 3338dae3-8e6c-45e8-b4e2-a4ddc4d88c95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS® 3 SOFTWARE V1.4
• Version Model Number: 1.4
• 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	03573026617622 [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: 2023-07-12
• Device Publish Date: 2023-07-04

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