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Product Classification

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Device

susceptibility test discs, antimicrobial

Regulation Description

Antimicrobial susceptibility test disc.

Regulation Medical Specialty

Microbiology

Review Panel

Microbiology

Product Code

JTN

Submission Type

510(k)

Regulation Number

866.1620

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

CLSI/NCCLS M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards - Second Edition
CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
CLSI M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard - Second Edition
CLSI M27-S3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement
CLSI M02-A11 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Eleventh Edition
CLSI M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline - Third Edition
CLSI M44-A2 Method for Antifungal Disk Diffusion Suceptibility Testing of Yeast; Approved Guideline-Second Edition
CLSI M44-S3 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition

Guidance Document

Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs

Third Party Review

Eligible for Accredited Persons Program

Accredited Persons

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