Vietnam MOH registration 220002176/PCBB-BYT

They are conducting a qualitative antibody test for H.Pylori

VN: Họ khay thử xét nghiệm định tính kháng thể kháng H.Pylori

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered May 05, 2022

Registration details

Analysis ID: 220002176/PCBB-BYT
Submission ID: 000.00.04.G18-220323-0011
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: The Bioline™ H.Pylori Test is a qualitative test to detect antibodies of all classes (IgG, IgM, IgA, etc.) specific for Helicobacter pylori in human serum or plasma. The test aims to assist in diagnosing the risk of H.Pylori infection in patients with gastrointestinal symptoms. Positive samples should be confirmed by another test.

Dates and status

Registration Date: May 05, 2022

About this record

Access comprehensive regulatory information for They are conducting a qualitative antibody test for H.Pylori 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 220002176/PCBB-BYT and manufactured by Theo theo phụ lục.

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