Vietnam MOH registration 240002994/PCBB-HN

The Base IVD Cluster: Triglyceride, Glucose, Total Cholesterol

VN: Cụm IVD chất nền: Triglyceride, glucose, cholesterol toàn phần

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zybio Inc.·Registered Nov 01, 2024

Registration details

Analysis ID: 240002994/PCBB-HN
Submission ID: 000.00.19.H26-241029-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zybio Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Zybio Inc.
Authorized Representative: CÔNG TY TNHH KHOA HỌC P N D

Technical details

Intended Use: Triglyceride (TG) Kit (Enzymatic Method) (Product Code: 01.09.02.02.EC.01): In vitro test used to determine the concentration of triglycerides in human blood samples (serum). Clinically, the test is primarily used to support the diagnosis of hypertriglyceridemia. Triglyceride (TG) Kit (Enzymatic Method) (Product Code: 01.09.02.02.EC.02): In vitro test used to determine the concentration of triglycerides in human blood samples (serum). Clinically, the test is primarily used to support the diagnosis of hypertriglyceridemia. Glucose (GLU) Kit (Hexokinase Method) (Product Code: 1080201): In vitro test used to determine the concentration of glucose in human blood samples (serum or plasma). Clinically, the measurements are used to support the diagnosis of diabetes. Glucose (GLU) Kit (Hexokinase Method) (Product Code: 1080203): In vitro test used to determine the concentration of glucose in human blood samples (serum or plasma). Clinically, the measurements are used to support the diagnosis of diabetes. Total Cholesterol (CHOL) Kit (Enzymatic Method) (Product Code: 01.09.02.10.EC.01): In vitro test used to determine the concentration of total cholesterol (CHOL) in human blood samples (serum). Total Cholesterol (CHOL) Kit (Enzymatic Method) (Product Code: 01.09.02.10.EC.02): In vitro test used to determine the concentration of total cholesterol (CHOL) in human blood samples (serum).

Dates and status

Registration Date: Nov 01, 2024

About this record

Access comprehensive regulatory information for The Base IVD Cluster: Triglyceride, Glucose, Total Cholesterol 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 240002994/PCBB-HN and manufactured by Zybio Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KHOA HỌC P N D.

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