Vietnam MOH registration 240002351/PCBA-HN
VIASURE Pathogen DNA/RNA Extractor for the VIASURE V-Flex, 96-Well
VN: Bộ tách chiết DNA/RNA mầm bệnh VIASURE dành cho máy VIASURE V-Flex, 96 phản ứng
Vietnam·Risk Class TBYT Loại A·VIASURE DNA/RNA Pathogens Extraction Kit for VIASURE V-Flex, 96 prep·CERTEST BIOTEC, S.L.·Registered Oct 24, 2024Registration details
- Analysis ID
- 240002351/PCBA-HN
- Submission ID
- 000.00.19.H26-241021-0005
- Product Type
- VIASURE DNA/RNA Pathogens Extraction Kit for VIASURE V-Flex, 96 prep
- Product Code
- VS-EAP0296FX
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 isolate and purify the DNA and RNA of viruses, bacteria, parasites, and fungi from different clinical samples (nasal swab, saliva, sputum, stool, and urine) for subsequent diagnosis using the automatic VIASURE V-Flex Extraction System. The kit contains different reagents to process clinical samples in automated platforms and facilitates the detection of pathogens by 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 DNA/RNA Extractor for the VIASURE V-Flex, 96-Well 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 240002351/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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