Horopeg Human Immunodeficiency Virus Type 1 Virality Nucleic Acid Detection Reagent - Taiwan Registration c5b1537cb033ffc880f24f71681b6d53
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 c5b1537cb033ffc880f24f71681b6d53 and manufactured by Hologic LTD;; Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Hologic, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
c5b1537cb033ffc880f24f71681b6d53
DHA05603708300
Product Details
This product is a nucleic acid amplification assay 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 to assist in the clinical management of patients with HIV-1 infection. This product is not intended for HIV screening in blood or plasma donors.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
May 30, 2024
May 30, 2029