Orientia tsutsugamushi (O. tsutsugamushi) (16s rRNA) Qualitative Gen Test - Vietnam Registration 2402925ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Orientia tsutsugamushi (O. tsutsugamushi) (16s rRNA) Qualitative Gen 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 2402925ĐKLH/BYT-HTTB and manufactured by Wells Bio, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN GIẢI PHÁP Y TẾ VÀ KHOA HỌC SURAN.
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Device Details
Registration Details
2402925ĐKLH/BYT-HTTB
000.00.04.G18-230710-0003
careGENE™ Scrub Typhus Real-time PCR kit
MTH-N10082
Technical Details
The careGENE™ Scrub Typhus Real-time PCR kit is an in vitro diagnostic medical device to qualitatively detect the Orientia tsutsugamushi (O. tsutsugamushi) (16s rRNA) gene from whole blood samples (treated with K3-EDTA) of suspected scrub typhus patients using real-time PCR.
Dates and Status
Oct 22, 2024