Automated Immunoassay Analyzer - Vietnam Registration 2400170ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Automated Immunoassay Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400170ĐKLH/BYT-HTTB and manufactured by STRATEC SE. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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2400170ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2400170ĐKLH/BYT-HTTB

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Device Details

Automated Immunoassay Analyzer

VN: Máy xét nghiệm miễn dịch tự động

Risk Class TTBYT Loại D

Registration Details

Analysis ID

2400170ĐKLH/BYT-HTTB

Submission ID

19010413/ĐKLH-BYT-TB-CT

Product Type

LIAISON XL LAS

Product Code

I0050LAS

Technical Details

Intended Use

LIAISON XL LAS is an automated immunoassay analyzer used to measure the chemiluminescent reaction. The device is intended for in vitro diagnostic use, and must be operated by qualified personnel and only perform the chemiluminescent immunoassay tests designated by DiaSorin Italia S.p.A. LIAISON XL LAS is designed to be compatible with certain specific laboratory automation systems. Intended for professional use only.