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Quantitative CA 19-9 Test Kit - Vietnam Registration 2400871ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Quantitative CA 19-9 Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400871ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

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.

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2400871ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400871ĐKLH/BYT-HTTB
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Device Details

Quantitative CA 19-9 Test Kit
VN: Bộ xét nghiệm định lượng CA 19-9
Risk Class TTBYT Loại C

Registration Details

2400871ĐKLH/BYT-HTTB

000.00.04.G18-220628-0010

VIDAS®CA 19-9

30427

Company Information

FRANCE

BIOMERIEUX SA

Technical Details

VIDAS CA 19-9 is an automated quantitative test performed on VIDAS flow machines to measure the concentration of the 1116-NS-19-9 antigen in human serum or plasma (lithium heparin or EDTA anticoagulated) using the ELFA (Enzyme-Linked Fluorescence Assay) technique.

Dates and Status

Jun 24, 2024