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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOUS
Regulation Number 866.2050
Device Class 1