OUS · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2050
Classification
FDA Product Code
OUS
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.2050
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.