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Mass Spectrometry, Microorganism Identification, Blood Culture

Mass Spectrometry, Microorganism Identification, Blood Culture is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Mass Spectrometry, Microorganism Identification, Blood Culture
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QNJ

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Class 2

21 CFR 866.3378

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

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.