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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
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
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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