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Qualitative HIV-1 p24 Antigen and HIV-1 Antibody (including group O) and HIV-2 Control Material - Vietnam Registration 2403380ĐKLH/BYT-HTTB

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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2403380ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403380ĐKLH/BYT-HTTB
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Device Details

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
Risk Class TTBYT Loại D

Registration Details

2403380ĐKLH/BYT-HTTB

000.00.04.G18-231219-0002

PreciControl HIV; HIV-2+GrpO

06924115190

Company Information

GERMANY

Technical Details

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

Nov 06, 2024