Vietnam MOH registration 230003468/PCBB-HN

The IVD Base: Albumin (ALB), Total Cholesterol (CHO), Creatinine (CRE), Direct Bilirubin (DBIL), Glucose (GLU), Total Bilirubin (TBIL), Triglycerides (TG), Total Protein (TP), Uric Acid (UA), Urea

VN: Cụm IVD chất nền: Albumin (ALB), Cholesterol Toàn phần (CHO), Creatinine (CRE), Bilirubin Trực tiếp (DBIL), Glucose (GLU), Bilirubin Toàn phần (TBIL), Triglycerides (TG), Protein Toàn phần (TP), Uric Acid (UA), Urea
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 27, 2023
Registration details
Analysis ID
230003468/PCBB-HN
Submission ID
000.00.19.H26-231221-0036
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Technical details
Intended Use
-Albumin Quantitative Assay: Used in in vitro diagnosis to quantify the concentration of Albumin in serum or plasma. -Total Cholesterol Quantitative Assay: Used in in vitro diagnosis to quantify the concentration of cholesterol in serum and plasma. -Creatinine Quantitative Assay: Used in in vitro diagnosis to determine the concentration of Creatinine in serum, plasma, or urine. -Direct Bilirubin Quantitative Assay: Used in in vitro diagnosis to determine the concentration of Direct Bilirubin in serum or plasma. -Glucose Quantitative Assay: Used in in vitro diagnosis to determine the concentration of glucose in serum. -Glucose Quantitative Assay: Used in in vitro diagnosis to determine the concentration of glucose in serum and plasma of humans. -Total Bilirubin Quantitative Assay: Used in in vitro diagnosis to determine the concentration of Total Bilirubin (TBIL) in serum or plasma of humans. -Triglycerides Quantitative Assay: Used in in vitro diagnosis to determine the concentration of Triglycerides (TG) in serum of humans. -Total Protein Quantitative Assay: Used in in vitro diagnosis to determine the concentration of total protein (TP) in serum or plasma of humans. -Uric Acid Quantitative Assay: Used in in vitro diagnosis to determine the concentration of Uric Acid in serum, plasma, or urine. -Urea Quantitative Assay: Used in in vitro diagnosis to determine the concentration of Urea in serum, plasma, or urine.
Dates and status
Registration Date
Dec 27, 2023
About this record

Access comprehensive regulatory information for The IVD Base: Albumin (ALB), Total Cholesterol (CHO), Creatinine (CRE), Direct Bilirubin (DBIL), Glucose (GLU), Total Bilirubin (TBIL), Triglycerides (TG), Total Protein (TP), Uric Acid (UA), Urea in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230003468/PCBB-HN and manufactured by Theo theo phụ lục.

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