VITEK MS

JSON twin: https://www.healthaidb.com/software/vitek-ms.json

Company Name

bioMérieux

Product URL

https://www.biomerieux.com/us/en/our-offer/industry-products/vitek-ms-microbial-identification.html

Company URL

https://www.biomerieux.com

Categories

• diagnostic Support
• laboratory Testing
• laboratory Automation
• Diagnostic
• Clinical Microbiology

Summary

VITEK MS is an automated mass spectrometry system that rapidly identifies microorganisms, including bacteria and fungi, to support informed clinical decisions.

Description

VITEK MS utilizes Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology to provide rapid and accurate microbial identification. Its comprehensive FDA 510(k) cleared database includes mycobacteria, Nocardia, molds, Brucella, Candida auris, and Elizabethkingia anophelis. The system integrates identification and antimicrobial susceptibility testing (AST) results, enhancing laboratory workflow efficiency. Features include robust identification with the Advanced Spectra Classifier, seamless ID/AST integration, and complete traceability with barcode-enabled reagents and disposables. VITEK MS is designed for high-throughput testing, capable of processing up to 192 samples per run, and offers customizable databases to accommodate facility-specific strains. The system is validated by AOAC RI, approved by AFNOR, certified by ISO 16140, and FDA-cleared, ensuring reliability and compliance with industry standards.

Api Available

unknown

Certifications

• FDA 510(k) clearance for mycobacteria, Nocardia, and molds

Company Founding

1963

Company Offices

• United States
• France
• Germany
• Italy
• China
• Japan
• India
• Brazil
• Mexico
• South Korea

Compliance

• 21 CFR Part 11
• FDA 510(k) clearance

Customers

Data Residency

US/EU regions

Data Standards

• FDA 510(k) database
• MALDI-TOF technology

Deployment Model

• on_prem
• SaaS

Features

• Automated mass spectrometry microbial identification
• MALDI-TOF technology
• FDA 510(k) cleared database for bacteria and fungi
• Identification of mycobacteria, Nocardia, molds, Brucella, Candida auris, and Elizabethkingia anophelis
• Advanced Spectra Classifier for robust and accurate identifications
• Seamless integration of ID/AST results for optimized workflow
• 4-slide capacity for parallel sample preparation
• 48 sample spots per target slide, 192 isolates per run
• Guided slide preparation for ID and connection with AST using VITEK MS Prep Station
• Same-day ID and AST results with VITEK 2
• Minimal hands-on time for laboratory personnel
• Variable throughput for large and small labs (1-192 samples/run)
• Barcodes on reagents and disposables for traceability
• Disposable slides to reduce contamination risk and chemical hazards
• Automatic verification of operation, tuning, and alignment
• LIMS compatibility for data tracking and compliance
• 21 CFR Part 11 compliance readiness
• VILINK Remote diagnostics & resolution to optimize system uptime

Id

SW0634

Integration Partners

Integrations

• VITEK 2
• LIMS systems
• MYLA middleware
• VILINK connectivity solution

Languages Supported

• English
• French
• Spanish
• German
• Italian
• Dutch
• Portuguese
• Chinese
• Japanese
• Korean

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• VITEK MS Prep Station
• MYLA middleware
• VILINK connectivity solution

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Disposable slides to reduce contamination risk and chemical hazards
• LIMS compatibility for data tracking and compliance

Product Code

SW0634

Product Name

VITEK MS

Ratings

Regions Available

• United States
• Europe
• Asia
• Latin America

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Barcodes on reagents and disposables for traceability
• Automatic verification of operation, tuning, and alignment

Specialties

• Microbial Identification
• Antimicrobial Susceptibility Testing
• Clinical Diagnostics

Support Channels

System Requirements

200 VAC, 50/60 Hz, 1000 VA single phase OR 230 VAC, 50/60 Hz, 1000 VA single phase; ambient temperature 18° to 26° C

Target Users

• clinicians
• microbiologists
• laboratory technicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "VITEK MS",
  "company_name": "bioMérieux",
  "product_url": "https://www.biomerieux.com/us/en/our-offer/industry-products/vitek-ms-microbial-identification.html",
  "company_url": "https://www.biomerieux.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0634",
  "summary": "VITEK MS is an automated mass spectrometry system that rapidly identifies microorganisms, including bacteria and fungi, to support informed clinical decisions.",
  "description": "VITEK MS utilizes Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology to provide rapid and accurate microbial identification. Its comprehensive FDA 510(k) cleared database includes mycobacteria, Nocardia, molds, Brucella, Candida auris, and Elizabethkingia anophelis. The system integrates identification and antimicrobial susceptibility testing (AST) results, enhancing laboratory workflow efficiency. Features include robust identification with the Advanced Spectra Classifier, seamless ID/AST integration, and complete traceability with barcode-enabled reagents and disposables. VITEK MS is designed for high-throughput testing, capable of processing up to 192 samples per run, and offers customizable databases to accommodate facility-specific strains. The system is validated by AOAC RI, approved by AFNOR, certified by ISO 16140, and FDA-cleared, ensuring reliability and compliance with industry standards.",
  "categories": [
    "diagnostic Support",
    "laboratory Testing",
    "laboratory Automation",
    "Diagnostic",
    "Clinical Microbiology",
    "Laboratory Automation"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "microbiologists",
    "laboratory technicians"
  ],
  "specialties": [
    "Microbial Identification",
    "Antimicrobial Susceptibility Testing",
    "Clinical Diagnostics"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Latin America"
  ],
  "languages_supported": [
    "English",
    "French",
    "Spanish",
    "German",
    "Italian",
    "Dutch",
    "Portuguese",
    "Chinese",
    "Japanese",
    "Korean"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "France",
    "Germany",
    "Italy",
    "China",
    "Japan",
    "India",
    "Brazil",
    "Mexico",
    "South Korea"
  ],
  "company_founding": "1963",
  "deployment_model": [
    "on_prem",
    "SaaS"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "Automated mass spectrometry microbial identification",
    "MALDI-TOF technology",
    "FDA 510(k) cleared database for bacteria and fungi",
    "Identification of mycobacteria, Nocardia, molds, Brucella, Candida auris, and Elizabethkingia anophelis",
    "Advanced Spectra Classifier for robust and accurate identifications",
    "Seamless integration of ID/AST results for optimized workflow",
    "4-slide capacity for parallel sample preparation",
    "48 sample spots per target slide, 192 isolates per run",
    "Guided slide preparation for ID and connection with AST using VITEK MS Prep Station",
    "Same-day ID and AST results with VITEK 2",
    "Minimal hands-on time for laboratory personnel",
    "Variable throughput for large and small labs (1-192 samples/run)",
    "Barcodes on reagents and disposables for traceability",
    "Disposable slides to reduce contamination risk and chemical hazards",
    "Automatic verification of operation, tuning, and alignment",
    "LIMS compatibility for data tracking and compliance",
    "21 CFR Part 11 compliance readiness",
    "VILINK Remote diagnostics & resolution to optimize system uptime"
  ],
  "optional_modules": [
    "VITEK MS Prep Station",
    "MYLA middleware",
    "VILINK connectivity solution"
  ],
  "integrations": [
    "VITEK 2",
    "LIMS systems",
    "MYLA middleware",
    "VILINK connectivity solution"
  ],
  "data_standards": [
    "FDA 510(k) database",
    "MALDI-TOF technology"
  ],
  "api_available": "unknown",
  "system_requirements": "200 VAC, 50/60 Hz, 1000 VA single phase OR 230 VAC, 50/60 Hz, 1000 VA single phase; ambient temperature 18° to 26° C",
  "compliance": [
    "21 CFR Part 11",
    "FDA 510(k) clearance"
  ],
  "certifications": [
    "FDA 510(k) clearance for mycobacteria, Nocardia, and molds"
  ],
  "security_features": [
    "Barcodes on reagents and disposables for traceability",
    "Automatic verification of operation, tuning, and alignment"
  ],
  "privacy_features": [
    "Disposable slides to reduce contamination risk and chemical hazards",
    "LIMS compatibility for data tracking and compliance"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0634",
  "slug": "vitek-ms",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/vitek-ms.json"
  }
}