DeviceClearance

Product code PEN— Microbiology

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Classification name
Gram-Negative Bacteria And Associated Resistance Markers
Device class
Class 2
Regulation
21 CFR 866.3365
Advisory panel
Microbiology
Total cleared
11
First cleared
Most recent

FDA classification definition

“A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.”

— U.S. Food and Drug Administration, device classification record for product code PEN under 21 CFR 866.3365, via openFDA

Market context for product code PEN

FDA has cleared 11 devices under product code PEN between 2013 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEN

Adverse events under product code PEN

product code PEN
Death
7
Total
7

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PEN

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