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Qualitative DNA Testing of Mycobacterium tuberculosis - Vietnam Registration 2403183ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative DNA Testing of Mycobacterium tuberculosis 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 2403183ĐKLH/BYT-HTTB and manufactured by Bioneer Corporation. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.

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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2403183ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403183ĐKLH/BYT-HTTB
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Device Details

Qualitative DNA Testing of Mycobacterium tuberculosis
VN: Thuốc thử xét nghiệm định tính ADN của Mycobacterium tuberculosis
Risk Class TTBYT Loại C

Registration Details

2403183ĐKLH/BYT-HTTB

000.00.04.G18-201211-0010

AccuPower® MTB Real-Time PCR Kit

MTB-1111

Company Information

REPUBLIC OF

Bioneer Corporation

Technical Details

AccuPower® MTB Real-Time PCR Kit is an in vitro diagnostic kit designed to detect the DNA of Mycobacterium tuberculosis (MTB) in clinical samples: sputum, bronchoalveolar lavage (BAL) or urine through real-time polymerase chain reaction (PCR). This kit is a qualitative test intended for professional use only.

Dates and Status

Nov 02, 2024