Horopeg Human Immunodeficiency Virus Type 1 Virality Nucleic Acid Detection Reagent - Taiwan Registration 4a0e00ae5dd0df352fd8c7e75f682f8d
Access comprehensive regulatory information for Horopeg Human Immunodeficiency Virus Type 1 Virality Nucleic Acid Detection Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 4a0e00ae5dd0df352fd8c7e75f682f8d and manufactured by Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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Device Details
Product Details
This product is a nucleic acid amplification detection reagent for in vitro diagnostics for the detection and quantification of human immunodeficiency virus type 1 (HIV-1) RNA groups M, N and O on a fully automated Panther system. This product is used to assist in the diagnosis of HIV-1 infection and in the clinical management of HIV-1 infected patients. This product is not intended for HIV screening for blood or plasma donations.
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
May 04, 2023
May 04, 2028