IVD Department for Quantitative and Semi-Quantitative Testing of IgG Antibodies - Vietnam Registration 230002571/PCBB-HCM
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.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
230002571/PCBB-HCM
000.00.19.H29-231114-0011
Vitrotest Helicobacter-IgG
TK046
Technical Details
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
Nov 21, 2023