IVD Department Qualitative/Quantitative IgM Antibody Test for Helicobacter pylori - Vietnam Registration 230002572/PCBB-HCM
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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Device Details
Registration Details
230002572/PCBB-HCM
000.00.19.H29-231114-0004
Vitrotest Helicobacter-IgM
TK048
Technical Details
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
Nov 21, 2023