Vietnam MOH registration 2400870ĐKLH/BYT-HTTB

Quantitative CEA Test Kit

VN: Bộ xét nghiệm định lượng CEA

Vietnam·Risk Class TTBYT Loại C·VIDAS® CEA (S)·BIOMERIEUX SA·Registered Jun 24, 2024

Registration details

Analysis ID: 2400870ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220627-0015
Product Type: VIDAS® CEA (S)
Product Code: 30453

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 CEA is a quantitative test performed on the VIDAS instrument to quantify Carcinoembryonic (CEA) in serum or plasma (lithium heparin 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 CEA 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 2400870ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

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