Quantitative Immunoassay Control Material 8 Parameters - Vietnam Registration 2401190ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative Immunoassay Control Material 8 Parameters 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 2401190ĐKLH/BYT-HTTB and manufactured by DiaSorin Deutschland GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
2401190ĐKLH/BYT-HTTB
19010416/ĐKLH-BYT-TB-CT
LIAISON Multi-Control Tumour Markers
319109
Technical Details
The LIAISON Multi-Control Tumour Markers control material (containing the analytes: AFP, CA 125 II, CA 15-3, CA 19-9, CEA, Ferritin, HCG and β2-Microglobulin) is used in CLIA LIAISON immunoassays to assess the reliability of test runs. The performance characteristics of the LIAISON Multi-Control Tumour Markers control material have not been established for any other test or system, except for the LIAISON, LIAISON XL and LIAISON XS automated immunoassay systems.
Dates and Status
Jul 22, 2024