DeviceClearance

Product code OUS— Microbiology

KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT

Classification name
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
Device class
Class 1
Regulation
21 CFR 866.2050
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OUS under 21 CFR 866.2050, via openFDA

Market context for product code OUS

FDA has cleared 2 devices under product code OUS between 2011 and 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code OUS

Recent clearances under product code OUS

Data sourced from openFDA. This site is unofficial and independent of the FDA.