VIDAS®3 DILUTION CUP

GUDID 03573026377427

The VIDAS®3 can perform dilutions and manage two dilution cup racks holding 16 cups each.

BIOMERIEUX SA

Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 03573026377427
• NIH Device Record Key: 124b1ee7-0a9c-46f5-be6c-04cfd0aacb9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS®3 DILUTION CUP
• Version Model Number: VIDAS®3 DILUTION CUP
• 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: true
• Lot Batch: true
• 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	03573026377427 [Package]; Contains: 03573026612849; Package: [44 Units]; In Commercial Distribution
GS1	03573026612849 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2020-05-28

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