Culture Media, Antifungal, Susceptibility Test

Device Code: 3492

Product Code(s): MJE

Device Classification Information

• Device Type ID: 3492
• Device Name: Culture Media, Antifungal, Susceptibility Test
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.1700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MJE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-204 CLSI M27-A3
  Reference Method For Broth Dilution Antifungal Susceptibility Testing Of Yeasts
• 7-215 CLSI M44-A2 Vol. 29 No. 17 Replaces M44-A Vol. 24 No. 15
  Method For Antifungal Disk Diffusion Susceptibility Testing Of Yeast; Approved Guideline-Second Edition
• 7-217 CLSI M60 1st Edition
  Performance Standards For Antifungal Susceptibility Testing Of Yeasts
• 7-243 CLSI M51-A (Replaces M51-P)
  Method For Antifungal Disk Diffusion Susceptibility Testing Of Nondermatophyte Filamentous Fungi; Approved Guideline
• 7-276 CLSI M38 3rd Edition
  Reference Method For Broth Dilution Antifungal Susceptibility Testing Of Filamentous Fungi
• 7-278 CLSI M27 4th Edition
  Reference Method For Broth Dilution Antifungal Susceptibility Testing Of Yeasts

Total Product Life Cycle

• Device Type ID: 3492
• Device: Culture Media, Antifungal, Susceptibility Test
• Product Code: MJE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• CFR Regulation Number: 866.1700 [🔎]

TPLC Last Update: 2019-04-02 20:31:06