Vietnam MOH registration 230002571/PCBB-HCM

IVD Department for Quantitative and Semi-Quantitative Testing of IgG Antibodies

VN: Bộ IVD xét nghiệm định lượng và bán định lượng kháng thể IgG

Vitrotest® Helicobacter-IgG

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

Registration details

Analysis ID: 230002571/PCBB-HCM
Submission ID: 000.00.19.H29-231114-0011
Product Type: Vitrotest Helicobacter-IgG
Product Code: TK046

Company information

Manufacturer: Vitrotest Bioreagent LLC

Technical details

Intended Use: The Vitrotest® Helicobacter-IgG test is an enzyme-linked immunosorbent assay (ELISA) designed to quantitatively and semi-quantitatively determine the levels of IgG 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 the open system automated ELISA analysis system

Dates and status

Registration Date: Nov 21, 2023

About this record

Access comprehensive regulatory information for IVD Department for Quantitative and Semi-Quantitative Testing of IgG Antibodies 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 230002571/PCBB-HCM and manufactured by Vitrotest Bioreagent LLC.

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