Taiwan FDA registration e6554d4353e8ddda3d0b97b26f7180e7

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

TW: 羅氏全自動達可愛滋定性核酸檢驗套組第2代

Taiwan·Risk Class 3·MD·ROCHE MOLECULAR SYSTEMS, INC.·Registered Jun 22, 2015 – Jun 22, 2025Expired

Registration details

Analysis ID: e6554d4353e8ddda3d0b97b26f7180e7
License Form: Ministry of Health Medical Device Import No. 027357
Customs Code: DHA05602735702

Company information

Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B4020 Analyze specific reagents
Import Information: Imported from abroad

Dates and status

Registration Date: Jun 22, 2015
Expiry Date: Jun 22, 2025

About this record

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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