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Galectin-3 In Vitro Diagnostic Assay

Galectin-3 In Vitro Diagnostic Assay is a medical device type in the Clinical Chemistry 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
Galectin-3 In Vitro Diagnostic Assay
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OSX

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Class 2

21 CFR 862.1117

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Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

Definition

Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.