VITEK® MS PRIME

GUDID 03573026611422

MALDI-Tof Mass Spectometry system used for microbial identification

BIOMERIEUX SA

Microbial identification mass spectrometry system IVD

• Primary Device ID: 03573026611422
• NIH Device Record Key: 763b0c54-2fce-42ad-881f-a20017128c11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK® MS PRIME
• Version Model Number: 423281
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026611422 [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: 2022-05-03
• Device Publish Date: 2022-04-25

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