Vietnam MOH registration 2403587ĐKLH/BYT-HTTB

IVD Department Qualitative Antibody Test for Trypanosoma cruzi

VN: Bộ IVD xét nghiệm định tính kháng thể kháng Trypanosoma cruzi

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403587ĐKLH/BYT-HTTB
Submission ID: 18008072/ĐKLH-BYT-TB-CT
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 Chagas: An in vitro diagnostic test used to qualitatively determine antibodies against Trypanosoma cruzi (T. cruzi, the causative agent of Chagas disease) in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) test is used on the Elecsys and cobas e diagnostic platforms. PreciControl Chagas: PreciControl Chagas is used to monitor the quality of the Elecsys Chagas test on the Elecsys and cobas e diagnostic platforms.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for Trypanosoma cruzi 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 2403587ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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