VITEK® MS FA

GUDID 03573026362843

VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used exclusively with the VITEK ® MS instrument.

BIOMERIEUX SA

Microbial identification mass spectrometry system IVD

• Primary Device ID: 03573026362843
• NIH Device Record Key: 2a41b005-cca0-4c83-81c4-da2b443a60ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK® MS FA
• Version Model Number: VITEK® MS FA
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026362843 [Package]; Contains: 03573026555559; Package: [5 Units]; In Commercial Distribution
GS1	03573026555559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN130013

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-04-29
• Device Publish Date: 2016-12-19

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