Vietnam MOH registration 240002350/PCBA-HN

VIASURE Pathogen Extraction Kit for VIASURE V-Flex, 96 reactions

VN: Bộ tách chiết mầm bệnh từ mẫu máu VIASURE cho VIASURE V-Flex, 96 phản ứng

Vietnam·Risk Class TBYT Loại A·VIASURE Blood Pathogens Extraction Kit for VIASURE V-Flex, 96 prep·CERTEST BIOTEC, S.L.·Registered Oct 24, 2024

Registration details

Analysis ID: 240002350/PCBA-HN
Submission ID: 000.00.19.H26-241021-0004
Product Type: VIASURE Blood Pathogens Extraction Kit for VIASURE V-Flex, 96 prep
Product Code: VS-EAB0196FX

Company information

Manufacturer: CERTEST BIOTEC, S.L.
Manufacturer Country: SPAIN
Product Owner: Certest Biotec, S.L
Authorized Representative: CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH

Technical details

Intended Use: 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

Registration Date: Oct 24, 2024

About this record

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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