Vietnam MOH registration 240002057/PCBB-HCM

The IVD Base: DBIL, TBIL

VN: Cụm IVD chất nền: DBIL, TBIL

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Registered Sep 11, 2024

Registration details

Analysis ID: 240002057/PCBB-HCM
Submission ID: 000.00.19.H29-240828-0042
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: Atellica CH D_TBiL: The Atellica CH Diazo Total Bilirubin (D_TBil) test is used for in vitro diagnosis to quantify total bilirubin in human serum and plasma by the Atellica CH Analyzer. The measured value of total bilirubin (a compound formed in the normal and abnormal breakdown of red blood cells) is used in the diagnosis and treatment of liver, hemolysis, and metabolic disorders, including hepatitis and obstructive jaundice. Atellica CH D_DBiL: The Atellica CH Diazo Direct Bilirubin (D_DBil) test is used for in vitro diagnosis to quantify direct bilirubin in human serum and plasma by the Atellica CH Analyzer. The measured value of direct bilirubin (a compound formed in the normal and abnormal breakdown of red blood cells) is used in the diagnosis and treatment of liver, hemolysis, and metabolic disorders, including hepatitis and obstructive jaundice.

Dates and status

Registration Date: Sep 11, 2024

About this record

Access comprehensive regulatory information for The IVD Base: DBIL, TBIL in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002057/PCBB-HCM. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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