Vietnam MOH registration 2402918ĐKLH/BYT-HTTB

Qualitative Antibody Test for HCV

VN: Khay thử xét nghiệm định tính kháng thể kháng HCV
Vietnam flagVietnam·Risk Class TTBYT Loại D·GenBody HCV·GenBody Inc.·Registered Oct 22, 2024
Registration details
Analysis ID
2402918ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230819-0008
Product Type
GenBody HCV
Product Code
Theo phụ lục
Company information
Manufacturer
GenBody Inc.
Manufacturer Country
Theo theo phụ lục
Product Owner
GenBody Inc.
Technical details
Intended Use
GenBody HCV is an immunoassay chromatography test kit for qualitative detection of HCV antibodies in plasma, serum, and whole blood of humans. This kit is intended for professional use and as an initial screening test. Samples that react must be confirmed by additional testing, such as nucleic acid testing and other immunoassays.
Dates and status
Registration Date
Oct 22, 2024
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About this record

Access comprehensive regulatory information for Qualitative Antibody Test for HCV 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 2402918ĐKLH/BYT-HTTB and manufactured by GenBody Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ĐẦU TƯ THIẾT BỊ CÔNG NGHỆ NTN GLOBAL.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Hangzhou AllTest Biotech Co., Ltd, BIOMERIEUX SA, and 2 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.

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