OUSClass I
Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
Microbiology · 21 CFR 866.2050
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.
MDR events1All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Unspecified1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
2 clearances for this product code