VIDAS® 3 SOFTWARE V1.4

GUDID 03573026617622

VIDAS 3 V1.4 Software

BIOMERIEUX SA

Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory 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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