Roche novel coronavirus and influenza A/B virus rapid antigen test reagent - Taiwan Registration 33a22878a18255749441ebf58a54d600
Access comprehensive regulatory information for Roche novel coronavirus and influenza A/B virus rapid antigen test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 33a22878a18255749441ebf58a54d600 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Registration Details
33a22878a18255749441ebf58a54d600
DHA05603706001
Product Details
This product is a rapid immunochromatography assay that can simultaneously qualitatively detect and distinguish the novel coronavirus nucleocapsid protein and influenza A virus and influenza B virus antigens present in human nasopharyngeal swab specimens. This product has not been tested for suitability for the identification of type A, H5 and H7 subtypes.
B Hematology, Pathology and Genetics;; A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
A.1660 Quality control materials (analytical and non-analytical); C.3328 Influenza Virus Antigen Rapid Test System;; B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Feb 15, 2024
Feb 15, 2029