Vietnam MOH registration 2400621ĐKLH/BYT-HTTB
Qualitative nucleic acid test kit for SARS-CoV-2
VN: Bộ xét nghiệm định tính axit nucleic của SARS-CoV-2
Vietnam·Risk Class TTBYT Loại C·NGenePlex nCoV qRT-PCR Kit·NGeneBio Co., Ltd.·Registered May 10, 2024Registration details
- Analysis ID
- 2400621ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220208-0018
- Product Type
- NGenePlex nCoV qRT-PCR Kit
- Product Code
- NGB561V-096
Company information
- Manufacturer
- NGeneBio Co., Ltd.
- Manufacturer Country
- REPUBLIC OF
- Product Owner
- NGeneBio Co., Ltd.
- Authorized Representative
- CÔNG TY CỔ PHẦN VẬT TƯ KHOA HỌC BIOMEDIC
Technical details
- Intended Use
- 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
- Registration Date
- May 10, 2024
About this record
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.
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.
Free DatabasePowered by Pure Global AI300,000+ Devices