Vietnam MOH registration 230003520/PCBB-HN

IVD Quantitative Globulin Immune E (IgE) Test Kit

VN: Bộ IVD xét nghiệm định lượng Globulin miễn dịch E (IgE)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 31, 2023

Registration details

Analysis ID: 230003520/PCBB-HN
Submission ID: 000.00.19.H26-231226-0039
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: -Drug Test for Quantitative Measurement of Immune Globulin E (IgE): Used in in vitro diagnosis to determine the quantitative concentration of Immune Globulin E in serum or plasma. -Chemical Standard for Quantitative Measurement of Immune Globulin E (IgE): This is the chemical standard of the IGE test kit, intended for in vitro diagnosis only. -Control Material for Quantitative Measurement of Immune Globulin E (IgE): This is the control material of the IGE test kit, intended for in vitro diagnosis only.

Dates and status

Registration Date: Dec 31, 2023

About this record

Access comprehensive regulatory information for IVD Quantitative Globulin Immune E (IgE) Test Kit 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 230003520/PCBB-HN and manufactured by Theo theo phụ lục.

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