Qualitative RNA Test for SARS-CoV-2, Influenza A, and Influenza B - Vietnam Registration 2401185ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative RNA Test for SARS-CoV-2, Influenza A, and Influenza B in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2401185ĐKLH/BYT-HTTB and manufactured by Bioneer Corporation. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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Device Details
Registration Details
2401185ĐKLH/BYT-HTTB
000.00.04.G18-220526-0012
AccuPower® RV1 Multiplex Kit
RV1-2112
Technical Details
AccuPower® RV1 Multiplex Kit is an in vitro diagnostic kit intended to simultaneously or individually detect the RNA of SARS-CoV-2 (from sputum, nasal swab, and oral swab samples), Influenza A, and Influenza B (from nasal swab and oral swab samples) in respiratory specimens of humans through real-time polymerase chain reaction (Real-Time PCR). The qualitative test kit is intended for professional use only.
Dates and Status
Jul 22, 2024