I3CGlobal FDA 510k, IVDR February 18, 2025

Automated Hemoglobin System

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I3CGlobal FDA 510k, IVDR February 18, 2025

Acute Kidney Injury Test System

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I3CGlobal FDA 510k, IVDR February 17, 2025

Human Chorionic Gonadotropin (HCG) Test

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I3CGlobal FDA 510k, IVDR February 17, 2025

Calcium Test System

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I3CGlobal FDA 510k, IVDR February 17, 2025

Calcitonin Test System

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I3CGlobal FDA 510k, IVDR February 17, 2025

B-type Natriuretic Peptide Test

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I3CGlobal FDA 510k, IVDR February 17, 2025

Blood Gases (PCO2, PO2) and Blood pH Test System

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I3CGlobal FDA 510k, IVDR February 17, 2025

Bilirubin (total or direct) Test System

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I3CGlobal FDA 510k, IVDR February 14, 2025

Bilirubin (total and unbound) In the Neonate Test System

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