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Mass Spectrometry, Microorganism Identification, Blood Culture

FDA product code QNJ · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3378
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-12-27 – 2024-09-26

Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.

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