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Direct Blood Bacterial Nucleic Acid Detection System

FDA product code QBX · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3960
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-05-24 – 2024-02-08

Amplification, detection and identification of microbial pathogens directly from whole blood specimens

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