VITEK®MS

GUDID 03573026617851

VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument

BIOMERIEUX SA

Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD Mass spectrometry analyser calibration kit IVD

• Primary Device ID: 03573026617851
• NIH Device Record Key: f304ab8f-7c70-4cb8-80ac-681d1718e5e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK®MS
• Version Model Number: VITEK MS
• 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: true
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026617851 [Package]; Contains: 03573026626211; Package: [5 Units]; In Commercial Distribution
GS1	03573026626211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212461

FDA Product Code

• QBN: 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: 2024-03-18
• Device Publish Date: 2024-03-08

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