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Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

FDA product code OUS · 2 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.2050
Review panel
MI
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-05-05 – 2012-03-30

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.

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