Vietnam MOH registration 2400871ĐKLH/BYT-HTTB

Quantitative CA 19-9 Test Kit

VN: Bộ xét nghiệm định lượng CA 19-9

Vietnam·Risk Class TTBYT Loại C·VIDAS®CA 19-9·BIOMERIEUX SA·Registered Jun 24, 2024

Registration details

Analysis ID: 2400871ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220628-0010
Product Type: VIDAS®CA 19-9
Product Code: 30427

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: FRANCE
Product Owner: BIOMERIEUX SA
Authorized Representative: CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM

Technical details

Intended Use: VIDAS CA 19-9 is an automated quantitative test performed on VIDAS flow machines to measure the concentration of the 1116-NS-19-9 antigen in human serum or plasma (lithium heparin or EDTA anticoagulated) using the ELFA (Enzyme-Linked Fluorescence Assay) technique.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for Quantitative CA 19-9 Test Kit 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 2400871ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

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