Susceptibility Test Powders, Antimicrobial

Device Code: 3365

Product Code(s): JTT

Device Classification Information

• Device Type ID: 3365
• Device Name: Susceptibility Test Powders, Antimicrobial
• Regulation Description: Antimicrobial Susceptibility Test Powder.
• 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: 866.1640 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JTT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-261 CLSI M23 Fourth Edition (Replaces M23-A3)
  Development Of In Vitro Susceptibility Testing Criteria And Quality Control Parameters.
• 7-262 CLSI M45 3rd Edition
  Methods For Antimicrobial Dilution And Disk Susceptibility Testing Of Infrequently Isolated Or Fastidious Bacteria.

Total Product Life Cycle

• Device Type ID: 3365
• Device: Susceptibility Test Powders, Antimicrobial
• Product Code: JTT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Antimicrobial Susceptibility Test Powder.
• CFR Regulation Number: 866.1640 [🔎]

Device Problems
Incorrect Or Inadequate Test Results	2
Total Device Problems	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Remel Inc	II	Jun-07-2016

TPLC Last Update: 2019-04-02 20:28:16