Vietnam MOH registration 2403730ĐKLH/BYT-HTTB

IVD Department Qualitative Binding Assay for IgG Antibody Against Toxoplasma gondii

VN: Bộ IVD xét nghiệm định tính ái lực của kháng thể IgG kháng Toxoplasma gondii

Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Registered Nov 19, 2024

Registration details

Analysis ID: 2403730ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240913-0013
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: Elecsys Toxo IgG Avidity: An in vitro immunoassay used to determine the avidity of IgG antibodies against Toxoplasma gondii in human serum and plasma. The ECLIA (electrochemiluminescence immunoassay “ECLIA”) is used for the cobas e immunoassay system. PreciControl Toxo IgG Avidity: PreciControl Toxo IgG Avidity is used to control the quality of the Elecsys Toxo IgG Avidity immunoassay on the cobas e immunoassay system.

Dates and status

Registration Date: Nov 19, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative Binding Assay for IgG Antibody Against Toxoplasma gondii in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403730ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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