Vietnam MOH registration 2200106ĐKLH/BYT-TB-CT

Qualitative RNA Test for SARS-CoV-2

VN: Thuốc thử xét nghiệm định tính RNA của SARS-CoV-2
STANDARDTM M nCoV Real-Time Detection Kit
Vietnam flagVietnam·Risk Class TTBYT Loại D·STANDARD™ M nCoV Real-Time Detection Kit·SD Biosensor Inc.·Registered Nov 15, 2022
Registration details
Analysis ID
2200106ĐKLH/BYT-TB-CT
Submission ID
000.00.04.G18-220328-0023
Product Type
STANDARD™ M nCoV Real-Time Detection Kit
Product Code
Mã REF: M-NCOV-01 / Mã Catalog : 11NCO10
Company information
Manufacturer
SD Biosensor Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
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
Registration Date
Nov 15, 2022
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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.

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