Vietnam MOH registration 2401190ĐKLH/BYT-HTTB

Quantitative Immunoassay Control Material 8 Parameters

VN: Vật liệu kiểm soát xét nghiệm định lượng 8 thông số miễn dịch

Vietnam·Risk Class TTBYT Loại C·LIAISON Multi-Control Tumour Markers·DiaSorin Deutschland GmbH·Registered Jul 22, 2024

Registration details

Analysis ID: 2401190ĐKLH/BYT-HTTB
Submission ID: 19010416/ĐKLH-BYT-TB-CT
Product Type: LIAISON Multi-Control Tumour Markers
Product Code: 319109

Company information

Manufacturer: DiaSorin Deutschland GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: 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

Registration Date: Jul 22, 2024

About this record

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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