Device type
Gram-Negative Bacteria And Associated Resistance Markers
Product code PEN · Class II · 21 CFR 866.3365 · Microbiology
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Recent 510(k)s
Sep 24, 2026
K262168
QIAstat-Dx BCID GN Plus AMR Panel
QIAGEN GmbH
- PEN
- Class II
Recent recalls
No recalls in the archive for PEN.