Product Classification

• Device: system, test, automated, antimicrobial susceptibility, short incubation
• Regulation Description: Fully automated short-term incubation cycle antimicrobial susceptibility system.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LON
• Submission Type: 510(k)
• Regulation Number: 866.1645
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M100-S22 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement
• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition
• CLSI M07-A9 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard - Ninth Edition

Third Party Review

Not Third Party Eligible