VITEK®MS

GUDID 03573026621698

VITEK MS SW V1.1 + KB 3.2

BIOMERIEUX SA

Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD 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