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Automated Multicolor Fluorescent Imaging Cytometric Analysis System

Automated Multicolor Fluorescent Imaging Cytometric Analysis System is a medical device type in the Hematology 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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Automated Multicolor Fluorescent Imaging Cytometric Analysis System
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PMG

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Class 2

21 CFR 864.5220

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Hematology

Device Characteristics

No

No

No

Eligible

Definition

An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements.