Vietnam MOH registration 230002572/PCBB-HCM

IVD Department Qualitative/Quantitative IgM Antibody Test for Helicobacter pylori

VN: Bộ IVD xét nghiệm định tính/bán định lượng kháng thể IgM kháng Helicobacter pylori

Vitrotest® Helicobacter-IgM

Vietnam·Risk Class TTBYT Loại B·Vitrotest Helicobacter-IgM·Vitrotest Bioreagent LLC·Registered Nov 21, 2023

Registration details

Analysis ID: 230002572/PCBB-HCM
Submission ID: 000.00.19.H29-231114-0004
Product Type: Vitrotest Helicobacter-IgM
Product Code: TK048

Company information

Manufacturer: Vitrotest Bioreagent LLC

Technical details

Intended Use: The Vitrotest® Helicobacter-IgM test is an enzyme-linked immunosorbent assay (ELISA) designed to determine the qualitative and semi-quantitative presence of IgM antibodies against the CagA protein of Helicobacter pylori in human serum or plasma. The test can be performed using both automated pipetting and standard equipment, as well as automated ELISA systems with open architecture

Dates and status

Registration Date: Nov 21, 2023

About this record

Access comprehensive regulatory information for IVD Department Qualitative/Quantitative IgM Antibody Test for Helicobacter 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 230002572/PCBB-HCM and manufactured by Vitrotest Bioreagent LLC.

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