Qualitative RNA Test for SARS-CoV-2 - Vietnam Registration 2200106ĐKLH/BYT-TB-CT
Access comprehensive regulatory information for Qualitative RNA Test for SARS-CoV-2 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 2200106ĐKLH/BYT-TB-CT and manufactured by SD Biosensor Inc..
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including SolGent Co., Ltd., Bioneer Corporation, 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.
Device Details
Registration Details
2200106ĐKLH/BYT-TB-CT
000.00.04.G18-220328-0023
STANDARD™ M nCoV Real-Time Detection Kit
Mã REF: M-NCOV-01 / Mã Catalog : 11NCO10
Technical Details
The STANDARD™ M nCoV Real-Time Detection kit is used to detect and identify the ORF1ab (RdRp) and E genes of SARS-CoV-2 in throat swab, nasal swab, and sputum samples, based on the principle of reverse transcription real-time PCR. This kit is useful in assisting the diagnosis of COVID-19. The test results are only for clinical reference and should not be used as the sole basis for diagnosis or exclusion.
Dates and Status
Nov 15, 2022
Qualitative RNA Test for SARS-CoV-2
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit
SolGent Co., Ltd.
2401184ĐKLH/BYT-HTTB
Qualitative RNA Test for SARS-CoV-2, Influenza A, and Influenza B
Bioneer Corporation
2401185ĐKLH/BYT-HTTB