Atellica CH Diazo Total Bilirubin (D_TBil)

• K Number: K251998
• Device Name: Atellica CH Diazo Total Bilirubin (D_TBil)
• Manufacturer: Siemens Healthcare Diagnostics, Inc.
• Date Cleared: 2026-02-27 ( 245 days)
• Product Code: CIG
• Regulation Number: 862.1110
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.