Immunoassay Analyzer - Vietnam Registration 2400177ĐKLH/BYT-HTTB

Access comprehensive regulatory information for 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 2400177ĐKLH/BYT-HTTB and manufactured by Abbott Laboratories. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

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2400177ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2400177ĐKLH/BYT-HTTB

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Device Details

Immunoassay Analyzer

VN: Máy phân tích miễn dịch

Risk Class TTBYT Loại D

Registration Details

Analysis ID

2400177ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-210728-0040

Product Type

Alinity i Processing Module

Product Code

03R65-01

Technical Details

Intended Use

The Alinity i Test Module (Product Code: 03R6501) is indicated for in vitro diagnosis (in the test tube). The Alinity i Test Module is a fully automated, continuous random access immunoassay system that performs priority and automated retest using the CMIA (chemiluminescent microparticle immunoassay) technology. The CMIA technology is used to detect the presence of antigens, antibodies, and analytes in the sample. The modular design of Alinity i allows for one or multiple test modules, in various configurations, to be connected to the system control module to form a single operational system.