Reagent/device, Inoculum Calibration

Device Code: 3405

Product Code(s): LIE

Device Classification Information

• Device Type ID: 3405
• Device Name: Reagent/device, Inoculum Calibration
• 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: LIE
• 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.

Total Product Life Cycle

• Device Type ID: 3405
• Device: Reagent/device, Inoculum Calibration
• Product Code: LIE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Antimicrobial Susceptibility Test Powder.
• CFR Regulation Number: 866.1640 [🔎]

TPLC Last Update: 2019-04-02 20:29:08