Vietnam MOH registration 2403380ĐKLH/BYT-HTTB

Qualitative HIV-1 p24 Antigen and HIV-1 Antibody (including group O) and HIV-2 Control Material

VN: Vật liệu kiểm soát xét nghiệm định tính kháng nguyên HIV-1 p24 và kháng thể kháng HIV-1 (bao gồm nhóm O) và HIV-2

Vietnam·Risk Class TTBYT Loại D·PreciControl HIV; HIV-2+GrpO·Roche Diagnostics GmbH·Registered Nov 06, 2024

Registration details

Analysis ID: 2403380ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231219-0002
Product Type: PreciControl HIV; HIV-2+GrpO
Product Code: 06924115190

Company information

Manufacturer: Roche Diagnostics GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: PreciControl HIV; HIV-2+GrpO is used to control the quality of the Elecsys HIV combi PT and Elecsys HIV Duo immunoassay tests on the cobas e analyzer.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Qualitative HIV-1 p24 Antigen and HIV-1 Antibody (including group O) and HIV-2 Control Material in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403380ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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