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U.S. Department of Health and Human Services

Product Classification

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Device methicillin resistant staphylococcus aureus/methicillin susceptible staphylococcus aureus blood culture test bt
Regulation Description Staphylococcal typing bacteriophage.
Definition The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.
Physical State Kit consisting of plastic capped tubes, pipets, lateral flow cassette and liquid reagents
Technical Method Bacteriophage amplification
Target Area Systemic, blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOUS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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