Vietnam MOH registration 2402914ĐKLH/BYT-HTTB

Machine for Extraction and Real Time PCR Automation

VN: Máy tách chiết và Real Time PCR tự động

Vietnam·Risk Class TBYT Loại D·NeuMoDx™ 288 Molecular System·NeuMoDx Molecular, Inc.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402914ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220822-0002
Product Type: NeuMoDx™ 288 Molecular System
Product Code: 500100

Company information

Manufacturer: NeuMoDx Molecular, Inc.
Manufacturer Country: UNITED STATES
Product Owner: NeuMoDx Molecular, Inc.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ KHOA HỌC VÀ CÔNG NGHỆ QMEDIC

Technical details

Intended Use: The NeuMoDx™ 288 Molecular System is designed for in vitro diagnostic (IVD) purposes to perform nucleic acid tests that have been qualified by NeuMoDx in clinical laboratories. The NeuMoDx 288 Molecular System has the capability to automatically extract and isolate nucleic acids from a variety of specimen types, as well as to automatically amplify and detect the target nucleic acid sequence by fluorescent PCR. The system enables laboratories to build qualitative and quantitative tests, using reagents and controls supplied by NeuMoDx.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Machine for Extraction and Real Time PCR Automation in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại D medical device is registered under number 2402914ĐKLH/BYT-HTTB and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VÀ CÔNG NGHỆ QMEDIC.

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