Vietnam MOH registration 2403580ĐKLH/BYT-HTTB

Khay thử xét nghiệm định tính kháng nguyên vi rút Adeno

Flowflex™ Respiratory Adenovirus Antigen Rapid Test Cassette

Vietnam·Risk Class TBYT Loại C·Respiratory Adenovirus Antigen Rapid Test Cassette·Acon Biotech (Hangzhou) Co., Ltd.·Registered Nov 14, 2024

Registration details

Analysis ID: 2403580ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231220-0012
Product Type: Respiratory Adenovirus Antigen Rapid Test Cassette
Product Code: L031-12135

Company information

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer Country: CHINA
Product Owner: Acon Biotech (Hangzhou) Co., Ltd.
Authorized Representative: CÔNG TY CỔ PHẦN Á CHÂU

Technical details

Intended Use: 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

Registration Date: Nov 14, 2024

About this record

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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