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COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 - Taiwan Registration e6554d4353e8ddda3d0b97b26f7180e7

Access comprehensive regulatory information for COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e6554d4353e8ddda3d0b97b26f7180e7 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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e6554d4353e8ddda3d0b97b26f7180e7
Registration Details
Taiwan FDA Registration: e6554d4353e8ddda3d0b97b26f7180e7
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Device Details

COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0
TW: ็พ…ๆฐๅ…จ่‡ชๅ‹•้”ๅฏๆ„›ๆป‹ๅฎšๆ€งๆ ธ้…ธๆชข้ฉ—ๅฅ—็ต„็ฌฌ2ไปฃ
Risk Class 3
MD

Registration Details

e6554d4353e8ddda3d0b97b26f7180e7

Ministry of Health Medical Device Import No. 027357

DHA05602735702

Company Information

United States

Product Details

This reagent uses the total nucleic acid amplification method to qualitatively detect human immunodeficiency virus type 1 (HIV-l) DNA and RNA (or total nucleic acid, TNA) in EDTA-containing human plasma or dried blood spots, and needs to be used with COBAS AmpliPrep instrument for automated sample processing and the use of COBAS TaqMan analyzer or COBAS TaqMan 48 analyzers perform automated nucleic acid amplification and detection. This reagent is used in individuals suspected of being infected with HIV-1 and is used for diagnostic purposes and cannot be used for screening. Measuring total HIV-1 nucleic acid can be used as an indicator of active HIV infection. Because babies born to HIV-l infected mothers may have anti-HIV-l antibodies from their mothers, testing for HIV-l nucleic acid in the baby indicates whether the baby is infected with HIV during the active phase. This reagent can also help diagnose HIV-l infection in adults.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Jun 22, 2015

Jun 22, 2025