"APEP" home coronavirus antigen test kit - Taiwan Registration cd80263525a5b8e2fd295797f5eec255
Access comprehensive regulatory information for "APEP" home coronavirus antigen test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number cd80263525a5b8e2fd295797f5eec255 and manufactured by Abbott Rapid Diagnostics Jena GmbH;; ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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Device Details
Registration Details
cd80263525a5b8e2fd295797f5eec255
DHA05603706406
Product Details
This product is a single-use in vitro rapid immunoassay with visually readable results, which is suitable for patients with COVID-19 symptoms to use nasal swab samples for qualitative detection of new coronavirus nucleocapsid protein antigen. This product is designed to allow untrained users to self-test and can be operated manually. A positive result cannot rule out the possibility of bacterial or other virus co-infection, and a negative result cannot completely rule out the possibility of new coronavirus infection, and the test result of this product cannot be used as the sole basis for diagnosis.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
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Dates and Status
Feb 27, 2024
Feb 27, 2029