IVD Department qualitative DNA test for Group B Streptococcus (GBS) - Vietnam Registration 2400885ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department qualitative DNA test for Group B Streptococcus (GBS) 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 2400885ĐKLH/BYT-HTTB and manufactured by DiaSorin Molecular LLC. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
2400885ĐKLH/BYT-HTTB
000.00.04.G18-210408-0026
Theo theo phụ lục
Theo phụ lục
Technical Details
1. Simplexa GBS Direct: The Simplexa GBS Direct test from DiaSorin Molecular is performed on the LIAISON MDX device to detect the presence of nucleic acid of Group B Streptococcus (GBS) in the vaginal/rectal swab of pregnant women, enriched in Lim Broth culture medium from 18 to 24 hours. The test results can be used to support the determination of the colonization status of the bacteria in pregnant women, but are not intended for the diagnosis or monitoring of GBS infection. 2. Simplexa GBS Positive Control Pack: The Simplexa GBS Positive Control Pack is used as a control material for the Simplexa GBS Direct test. Do not use this control material in conjunction with any other test or system.
Dates and Status
Jun 24, 2024