FDA Product Code PEN: Gram-negative Bacteria And Associated Resistance Markers
A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.
Leading manufacturers include Biofire Diagnostics, LLC.
1
Total
1
Cleared
14d
Avg days
2024
Since
List of Gram-negative Bacteria And Associated Resistance Markers devices cleared through 510(k)
1 devices
How to use this database
This page lists all FDA 510(k) submissions for Gram-negative Bacteria And Associated Resistance Markers devices (product code PEN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →