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Gram-Negative Bacteria And Associated Resistance Markers

FDA product code PEN · 10 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3365
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-06-21 – 2026-09-24

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

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