"Kaijie" Neomodis Hepatitis C Virus Nucleic Acid Test Reagent Group - Taiwan Registration 26dd8e3f3c759daac629932574b71d4b
Access comprehensive regulatory information for "Kaijie" Neomodis Hepatitis C Virus Nucleic Acid Test Reagent Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 26dd8e3f3c759daac629932574b71d4b and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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Device Details
Product Details
This product is an automated, in vitro nucleic acid amplification assay for the quantification of genotype 1 to 6 HCV RNA in human plasma and serum samples from patients with hepatitis C virus (HCV) infection with the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System). This product is indicated for adjunct to the management of patients with HCV infection. Not intended as a screening test for blood or blood products, or for diagnosing the clinical status of HCV infection.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Jan 23, 2024
Jan 23, 2029