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Gram-Positive Bacteria And Their Resistance Markers

FDA product code PAM · 6 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
2012-09-19 – 2026-08-06

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

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