Product Classification

• Device: culture media, antifungal, susceptibility test
• Regulation Description: Culture medium for antimicrobial susceptibility tests.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: MJE
• Submission Type: 510(k)
• Regulation Number: 866.1700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M44-S3 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition
• CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
• CLSI M27-S3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement
• CLSI M44-A2 Method for Antifungal Disk Diffusion Suceptibility Testing of Yeast; Approved Guideline-Second Edition

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.