VITEK®MS

GUDID 03573026621698

VITEK MS SW V1.1 + KB 3.2

BIOMERIEUX SA

Microbial identification mass spectrometry system IVD

• Primary Device ID: 03573026621698
• NIH Device Record Key: 4ee43db8-89b8-4241-b67c-e39f0606c470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK®MS
• Version Model Number: VITEK MS SW V1.1
• 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	03573026621698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162950

FDA Product Code

• PEX: System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

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: 2021-11-11
• Device Publish Date: 2021-11-03

On-Brand Devices [VITEK®MS]

• 03573026610418: DVD to install VITEK MS SW v1.0 and VITEK MS FlexPrep v1.0 for clinical customers
• 03573026621698: VITEK MS SW V1.1 + KB 3.2
• 03573026617851: VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument