FDA Product Code OUS: Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
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.
Leading manufacturers include Microphage, Inc..
2
Total
2
Cleared
148d
Avg days
2011
Since
FDA 510(k) Cleared Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt Devices (Product Code OUS)
2 devices
Cleared
Mar 30, 2012
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
Microphage, Inc.
Microbiology
35d
Cleared
May 05, 2011
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
Microphage, Inc.
Microbiology
260d