"Kaijie" Neomodis Hepatitis B Virus Nucleic Acid Test Reagent Set - Taiwan Registration 5ad4eb630addfb0d0c27b196fb213e01
Access comprehensive regulatory information for "Kaijie" Neomodis Hepatitis B Virus Nucleic Acid Test Reagent Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5ad4eb630addfb0d0c27b196fb213e01 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 use with the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System) for the quantification of HBV DNA from HBV genotypes A to H in human plasma and serum samples for patients infected with hepatitis B virus (HBV). This product is suitable for adjuvant treatment of patients with HBV infection. It is not intended as a screening test for blood or blood products, or as a diagnostic tool for the clinical status of HBV infection.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Aug 24, 2023
Aug 24, 2028