Vietnam MOH registration 2403042ĐKLH/BYT-HTTB

Genome Sequencing Reporting System

VN: Hệ thống giải trình tự gen

Vietnam·Risk Class TTBYT Loại C·PyroMark Q24 MDx·Zollner Elektronik AG, Zandt II Plant·Registered Nov 02, 2024

Registration details

Analysis ID: 2403042ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200826-0028
Product Type: PyroMark Q24 MDx
Product Code: 9001670

Company information

Manufacturer: Zollner Elektronik AG, Zandt II Plant
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: PyroMark Q24 MDx is a system for detecting changes at specific mutation positions in DNA that may have clinical significance. PyroMark Q24 MDx is used in in vitro diagnostic testing in Europe. The PyroMark Q24 MDx device can only be used in conjunction with the designated reagents of QIAGEN that are intended for use with the PyroMark Q24 MDx device for the applications described in the manual of the product. The PyroMark Q24 MDx system can only be used by professional users such as laboratory technicians and trained medical professionals who are knowledgeable about molecular biology techniques and the operation of the PyroMark Q24 MDx device

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for Genome Sequencing Reporting System 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 2403042ĐKLH/BYT-HTTB and manufactured by Zollner Elektronik AG, Zandt II Plant. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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