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U.S. Department of Health and Human Services

Product Classification

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Device system,test,genotypic detection,resistant markers,staphylococcus colonies
Regulation Description Antimicrobial susceptibility test powder.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMYI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices
Third Party Review Not Third Party Eligible
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