Product Classification

• Device: susceptibility test powders, antimycobacterial
• Regulation Description: Antimicrobial susceptibility test powder.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: MJA
• Submission Type: 510(k)
• Regulation Number: 866.1640
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition
• CLSI/NCCLS M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards - Second Edition

Third Party Review

Not Third Party Eligible