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Device
panels, test, susceptibility, antimicrobial
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Product Code
LTT
Premarket Review
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices (DMD)
Submission Type
510(k)
Regulation Number
866.1640
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Ineligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
7-262 CLSI M45 3rd Edition
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
7-279 CLSI M07 11th Edition
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
7-304 CLSI M23 5th Edition
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
7-308 CLSI M100, 31st Edition
Performance Standards for Antimicrobial Susceptibility Testing
7-312 CLSI M39 5th Edition
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
7-314 CLSI M27M44S, 3rd Edition
Performance Standards for Antifungal Susceptibility Testing of Yeasts
Third Party Review
Eligible for
510(k) Third Party Review Program
Accredited Persons
center for measurement standards of industrial
global quality and regulatory services
new york state department of health
regulatory technology services, llc
sgs north america
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