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U.S. Department of Health and Human Services

Product Classification
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Device system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
Regulation Description Antimicrobial susceptibility test powder.
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of mrsa colonization status for the prevention and control of mrsa infections in healthcare settings.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNQX
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  • Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm237235.htm] 
Third Party Review Not Third Party Eligible
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