Qualitative nucleic acid test kit for SARS-CoV-2 - Vietnam Registration 2400621ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative nucleic acid test kit for SARS-CoV-2 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 2400621ĐKLH/BYT-HTTB and manufactured by NGeneBio Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN VẬT TƯ KHOA HỌC BIOMEDIC.
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Device Details
Registration Details
2400621ĐKLH/BYT-HTTB
000.00.04.G18-220208-0018
NGenePlex nCoV qRT-PCR Kit
NGB561V-096
Technical Details
NGenePlex nCoV qRT-PCR Kit is a test kit that uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology to qualitatively detect the nucleic acids of SARS-CoV-2 from patients infected or suspected of being infected with COVID-19. - The NGenePlex nCoV qRT-PCR Kit is intended for use by specially trained professional laboratory personnel who are familiar with the RT-PCR technique and the use of in vitro diagnostic reagents. - The test kit is intended for qualitative detection of the nucleic acids of SARS-CoV-2 from patients infected or suspected of being infected with COVID-19, who present symptoms such as fever, cough, fatigue, shortness of breath, and loss of taste and smell. - The test sample is collected from the respiratory tract, such as the nasopharyngeal swab (NP) or throat swab (OP).
Dates and Status
May 10, 2024

