Product Classification

• Device: solution, antimicrobial
• Regulation Description: Antimicrobial susceptibility test powder.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LOP
• 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 Standard

• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.