Vietnam MOH registration 2401185ĐKLH/BYT-HTTB
Qualitative RNA Test for SARS-CoV-2, Influenza A, and Influenza B
VN: Thuốc thử xét nghiệm định tính RNA của SARS-CoV-2, cúm A và cúm B
Vietnam·Risk Class TTBYT Loại C·AccuPower® RV1 Multiplex Kit·Bioneer Corporation·Registered Jul 22, 2024Registration details
- Analysis ID
- 2401185ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220526-0012
- Product Type
- AccuPower® RV1 Multiplex Kit
- Product Code
- RV1-2112
Company information
- Manufacturer
- Bioneer Corporation
- Manufacturer Country
- REPUBLIC OF
- Product Owner
- Bioneer Corporation
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH
Technical details
- Intended Use
- 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
- Registration Date
- Jul 22, 2024
About this record
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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