Vietnam MOH registration 2402925ĐKLH/BYT-HTTB

Orientia tsutsugamushi (O. tsutsugamushi) (16s rRNA) Qualitative Gen Test

VN: Bộ xét nghiệm định tính gen Orientia tsutsugamushi (O. tsutsugamushi) (16s rRNA)

Vietnam·Risk Class TTBYT Loại C·careGENE™ Scrub Typhus Real-time PCR kit·Wells Bio, Inc.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402925ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230710-0003
Product Type: careGENE™ Scrub Typhus Real-time PCR kit
Product Code: MTH-N10082

Company information

Manufacturer: Wells Bio, Inc.
Manufacturer Country: REPUBLIC OF
Product Owner: Wells Bio, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN GIẢI PHÁP Y TẾ VÀ KHOA HỌC SURAN

Technical details

Intended Use: 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

Registration Date: Oct 22, 2024

About this record

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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