VIDAS®

GUDID 03573026140427

The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.

BIOMERIEUX SA

Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 03573026140427
• NIH Device Record Key: 32dc48a3-af6e-4532-93f1-3ee05834b790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS®
• Version Model Number: 99735
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026140427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891385

FDA Product Code

• DEW: Igg, Antigen, Antiserum, Control

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: 2023-01-12
• Device Publish Date: 2016-09-14

On-Brand Devices [VIDAS®]

• 03573026156985: VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate speci
• 03573026152482: The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.
• 03573026140427: The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.