MALDI Biotyper CA System

JSON twin: https://www.healthaidb.com/software/maldi-biotyper-ca-system.json

Company Name

Bruker

Product URL

https://www.bruker.com/products/microbiology-and-diagnostics/microbiology/identification/maldi-biotyper-ca-system.html

Company URL

https://www.bruker.com

Categories

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

Summary

The MALDI Biotyper CA System by Bruker is a mass spectrometry-based platform for rapid and accurate microbial identification in clinical settings.

Description

The MALDI Biotyper CA System utilizes Matrix-Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) mass spectrometry to identify microorganisms by analyzing their unique proteomic fingerprints. It offers a comprehensive FDA-cleared library covering over 480 species, including Gram-negative and Gram-positive bacteria, anaerobic bacteria, and yeasts. The system provides high accuracy comparable to 16S rRNA gene sequencing, with results available in minutes. It is designed for clinical microbiology laboratories to streamline workflows and enhance diagnostic efficiency. The system includes the microflex™ MALDI-TOF mass spectrometer, dedicated software, IVD-labeled reagents, and a 48-spot MALDI target. The MALDI Biotyper CA System is available for sale in the USA and Puerto Rico for prescription use only.

Api Available

no

Certifications

• FDA 510(k) clearance
• ISO 16140-6:2019
• AOAC-OMA certification

Company Founding

1960

Company Offices

• United States
• Germany
• Switzerland
• France
• United Kingdom
• Italy
• Japan
• China
• India
• Brazil

Compliance

• FDA 510(k) clearance
• ISO 16140-6:2019
• AOAC-OMA certification

Customers

Data Residency

US-only

Data Standards

• FDA-cleared library of 488 microbial species

Deployment Model

• on_prem

Features

• Microbial identification using MALDI-TOF mass spectrometry
• FDA-cleared library covering 488 microbial species
• High-throughput capability with 96-sample capacity
• Rapid identification with results in minutes
• User-friendly software with automated result interpretation
• Minimal sample preparation required
• Cost-effective compared to traditional methods
• Continuous operation with minimized maintenance
• Integration with BD Phoenix and BD EpiCenter systems
• Ready-to-use quality controls for precise identification

Id

SW0632

Integration Partners

Integrations

• BD Phoenix
• BD EpiCenter

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• MBT Filamentous Fungi Library
• MBT IVD Library Extension
• MBT Compass Reference Library

Os Platforms

• Windows

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Data anonymization
• Data minimization

Product Code

SW0632

Product Name

MALDI Biotyper CA System

Ratings

Regions Available

• United States
• Puerto Rico

Related Urls

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

Release Year

Security Features

• Audit logs
• User authentication

Specialties

• Microbiology
• Infectious Diseases
• Clinical Diagnostics

Support Channels

System Requirements

Windows OS

Target Users

• clinicians
• microbiologists
• laboratory technicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "MALDI Biotyper CA System",
  "company_name": "Bruker",
  "product_url": "https://www.bruker.com/products/microbiology-and-diagnostics/microbiology/identification/maldi-biotyper-ca-system.html",
  "company_url": "https://www.bruker.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0632",
  "summary": "The MALDI Biotyper CA System by Bruker is a mass spectrometry-based platform for rapid and accurate microbial identification in clinical settings.",
  "description": "The MALDI Biotyper CA System utilizes Matrix-Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) mass spectrometry to identify microorganisms by analyzing their unique proteomic fingerprints. It offers a comprehensive FDA-cleared library covering over 480 species, including Gram-negative and Gram-positive bacteria, anaerobic bacteria, and yeasts. The system provides high accuracy comparable to 16S rRNA gene sequencing, with results available in minutes. It is designed for clinical microbiology laboratories to streamline workflows and enhance diagnostic efficiency. The system includes the microflex™ MALDI-TOF mass spectrometer, dedicated software, IVD-labeled reagents, and a 48-spot MALDI target. The MALDI Biotyper CA System is available for sale in the USA and Puerto Rico for prescription use only.",
  "categories": [
    "diagnostic Support",
    "laboratory Testing",
    "laboratory Equipment",
    "Diagnostic",
    "Clinical Microbiology",
    "Laboratory Equipment"
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  "market_segment": [
    "enterprise",
    "smb"
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  "target_users": [
    "clinicians",
    "microbiologists",
    "laboratory technicians"
  ],
  "specialties": [
    "Microbiology",
    "Infectious Diseases",
    "Clinical Diagnostics"
  ],
  "regions_available": [
    "United States",
    "Puerto Rico"
  ],
  "languages_supported": [
    "English"
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  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "Switzerland",
    "France",
    "United Kingdom",
    "Italy",
    "Japan",
    "China",
    "India",
    "Brazil"
  ],
  "company_founding": "1960",
  "deployment_model": [
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  "os_platforms": [
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  "features": [
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    "FDA-cleared library covering 488 microbial species",
    "High-throughput capability with 96-sample capacity",
    "Rapid identification with results in minutes",
    "User-friendly software with automated result interpretation",
    "Minimal sample preparation required",
    "Cost-effective compared to traditional methods",
    "Continuous operation with minimized maintenance",
    "Integration with BD Phoenix and BD EpiCenter systems",
    "Ready-to-use quality controls for precise identification"
  ],
  "optional_modules": [
    "MBT Filamentous Fungi Library",
    "MBT IVD Library Extension",
    "MBT Compass Reference Library"
  ],
  "integrations": [
    "BD Phoenix",
    "BD EpiCenter"
  ],
  "data_standards": [
    "FDA-cleared library of 488 microbial species"
  ],
  "api_available": "no",
  "system_requirements": "Windows OS",
  "compliance": [
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    "ISO 16140-6:2019",
    "AOAC-OMA certification"
  ],
  "certifications": [
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    "ISO 16140-6:2019",
    "AOAC-OMA certification"
  ],
  "security_features": [
    "Audit logs",
    "User authentication"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0632",
  "slug": "maldi-biotyper-ca-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
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}