Qualitative antibody test for hepatitis C virus - Vietnam Registration 2301331ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative antibody test for hepatitis C virus in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2301331ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc..
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including DIA.PRO Diagnostic BioProbes S.r.l , Theo theo phụ lục, and 3 recent registrations in the same category. 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
2301331ĐKLH/BYT-HTTB
000.00.04.G18-230615-0011
OnSite HCV Ab Plus Rapid Test
R0023S
Technical Details
The OnSite HCV Ab Plus Rapid Test is a chromatographic immunoassay based on the principle of unidirectional flow, qualitatively detecting antibodies (IgG, IgM, IgA) against the hepatitis C virus (HCV) in the serum or plasma of humans. The test is intended to be used by healthcare professionals to aid in the diagnosis of HCV infection. Any use or interpretation of the results from this preliminary test must be based on clinical manifestations and the professional judgment of the physician. Other testing methods must be used to confirm the results obtained from this test kit.
Dates and Status
Oct 19, 2023
IVD Department Qualitative Antibody Test for Hepatitis C Virus (HCV)
Theo theo phụ lục
2300646ĐKLH/BYT-HTTB
Qualitative antibody test for Hepatitis C virus
HCV Ab
DIA.PRO Diagnostic BioProbes S.r.l
352808
Qualitative antibody test for Hepatitis C virus
HCV Ab
DIA.PRO Diagnostic BioProbes S.r.l
352832