FDA product code OSX

Galectin-3 In Vitro Diagnostic Assay

Clinical Chemistry·Class 2·21 CFR 862.1117
US regulatory classifications
US Product Code (FDA)
OSX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1117
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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.

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About this record

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.