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Flow Cytometry Calibrator

Flow Cytometry Calibrator 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
Multi-Country Intelligence
Flow Cytometry Calibrator
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PDX

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Class 2

21 CFR 864.5220

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Hematology

Device Characteristics

No

No

No

Eligible

Definition

Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.