VIASURE Pathogen Extraction Kit for VIASURE V-Flex, 96 reactions - Vietnam Registration 240002350/PCBA-HN
Access comprehensive regulatory information for VIASURE Pathogen Extraction Kit for VIASURE V-Flex, 96 reactions in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240002350/PCBA-HN and manufactured by CERTEST BIOTEC, S.L.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH.
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Device Details
Registration Details
240002350/PCBA-HN
000.00.19.H26-241021-0004
VIASURE Blood Pathogens Extraction Kit for VIASURE V-Flex, 96 prep
VS-EAB0196FX
Technical Details
Designed to separate and purify the DNA and RNA of viruses, bacteria, and parasites from different clinical samples (whole blood, serum, plasma, blood culture, cerebrospinal fluid, bronchoalveolar lavage, and fresh urine) for subsequent diagnostic purposes using the VIASURE V-Flex automated extraction system. The product contains different reagents to process clinical samples in the automated platform and facilitates the detection of pathogens with real-time PCR (qPCR and RT-qPCR). This product is not intended for diagnostic, preventive, or therapeutic purposes.
Dates and Status
Oct 24, 2024