Khay thử xét nghiệm định tính kháng nguyên vi rút Adeno - Vietnam Registration 2403580ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng nguyên vi rút Adeno in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403580ĐKLH/BYT-HTTB and manufactured by Acon Biotech (Hangzhou) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Á CHÂU.
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Device Details
Registration Details
2403580ĐKLH/BYT-HTTB
000.00.04.G18-231220-0012
Respiratory Adenovirus Antigen Rapid Test Cassette
L031-12135
Technical Details
Respiratory Adenovirus Antigen Rapid Test Cassette is a flow-through immunoassay device used to qualitatively detect Adeno virus antigen in nasal, tracheal, and throat wash specimens from individuals suspected of being infected with Adeno virus. The test is used to determine the presence of Adeno virus antigen. This antigen is commonly detected in respiratory tract specimens during the acute infection phase. A positive result indicates the presence of the virus antigen, but requires clinical correlation with the patient's medical history and other diagnostic information to determine the infection status. A positive result does not rule out the possibility of bacterial infection and co-infection with other types of viruses. A negative result does not rule out the possibility of Adeno virus infection and should not be the sole basis for treatment decisions or patient monitoring. Respiratory Adenovirus Antigen Rapid Test Cassette is designed for use by clinical laboratory technicians and trained healthcare professionals.
Dates and Status
Nov 14, 2024

