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Galectin-3 In Vitro Diagnostic Assay

FDA product code OSX · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1117
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2010-11-17 – 2010-11-17

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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