Qualitative RSV Antigen Test - Vietnam Registration 2300564ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative RSV Antigen Test 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 2300564ĐKLH/BYT-HTTB and manufactured by Abbott Diagnostics Scarborough, Inc..
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Device Details
Registration Details
2300564ĐKLH/BYT-HTTB
000.00.04.G18-210820-0024
BinaxNOW™ RSV Card
430-022
Technical Details
BinaxNOW™ RSV Card is an immuno-chromatographic qualitative test for the detection of respiratory tract cell fusion virus protein (RSV) antigens in nasopharyngeal wash specimens and nasopharyngeal swabs from symptomatic patients. The test serves a diagnostic purpose in the laboratory to assist in the diagnosis of viral respiratory tract infections in infants and young children under 5 years of age. A negative test result should be confirmed by cell culture.
Dates and Status
Jun 20, 2023