Immunoassay Analyzer
Vietnam·Risk Class TTBYT Loại D·Alinity i Processing Module·Abbott Laboratories·Registered Feb 04, 2024- Analysis ID
- 2400177ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210728-0040
- Product Type
- Alinity i Processing Module
- Product Code
- 03R65-01
- Manufacturer
- Abbott Laboratories
- Manufacturer Country
- UNITED STATES
- Product Owner
- Abbott Laboratories
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- 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.
- Registration Date
- Feb 04, 2024
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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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