Culture Media, Antimycobacteria, Susceptibility Test

Device Code: 3491

Product Code(s): MJD

Device Classification Information

• Device Type ID: 3491
• Device Name: Culture Media, Antimycobacteria, 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: MJD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-222 CLSI M24-A2 (Replaces M24-A)
  Susceptibility Testing Of Mycobacteria, Nocardiae And Other Aerobic Actinomycetes; Approved Standards - Second Edition

Total Product Life Cycle

• Device Type ID: 3491
• Device: Culture Media, Antimycobacteria, Susceptibility Test
• Product Code: MJD
• 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 20:31:05