Qualitative test for Streptococcus pneumoniae antigen - Vietnam Registration 2300565ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative test for Streptococcus pneumoniae antigen 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 2300565ĐKLH/BYT-HTTB and manufactured by Abbott Diagnostics Scarborough, Inc..
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Device Details
Registration Details
2300565ĐKLH/BYT-HTTB
000.00.04.G18-210820-0025
BinaxNOW™ Streptococcus pneumonia Antigen Card
710-000
Technical Details
BinaxNOW™ Streptococcus pneumoniae Antigen Card (BinaxNOW Streptococcus pneumoniae) is an in vitro rapid immunochromatographic (ICT) test to detect the presence of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebrospinal fluid (CSF) of patients with meningitis. The product is intended to be used in conjunction with culture and other methods to aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.
Dates and Status
Jun 20, 2023