OUS

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

Product code

OUS

Device name

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

Device class

Class 1

21 CFR

21 CFR 866.2050

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).