VITEK® MS-DS

GUDID 03573026359096

The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.

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

• Primary Device ID: 03573026359096
• NIH Device Record Key: 08350dd3-ab07-4735-b979-a86f5d3b17ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK® MS-DS
• Version Model Number: VITEK® MS-DS
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 4
• 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 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026359096 [Package]; Contains: 03573026554224; Package: [8 Units]; In Commercial Distribution
GS1	03573026554217 [Unit of Use]
GS1	03573026554224 [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: 2024-04-30
• Device Publish Date: 2016-12-23

Devices Manufactured by BIOMERIEUX SA

• 03573026359096 - VITEK® MS-DS: 2024-04-30The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.
• 03573026359096 - VITEK® MS-DS: 2024-04-30 The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.
• 03573026359119 - VITEK® MS: 2024-04-29 MALDI-Tof Mass Spectrometry system used for microbial identification
• 03573026362843 - VITEK® MS FA: 2024-04-29 VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used e
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• 03573026376604 - ETEST® Amoxicillin (AC): 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026377731 - ETEST® Flucytosine (FC): 2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions
• 03573026560690 - ETEST® Meropenem/Vaborbactam (MEV): 2024-04-15 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an