"Apei" new coronavirus antigen rapid test kit - Taiwan Registration 157dac7f2e825165e117eb2e5a4fcc6f
Access comprehensive regulatory information for "Apei" new coronavirus antigen rapid 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 157dac7f2e825165e117eb2e5a4fcc6f 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
157dac7f2e825165e117eb2e5a4fcc6f
DHA05603706600
Product Details
This product is a rapid test for in vitro diagnostics for the qualitative detection of the new coronavirus nucleocapsid protein antigen in nasal swabs or nasopharyngeal samples of patients with COVID-19 symptoms. This product is intended for use by professionals only. 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
QMS/QSD;; ๅง่จ่ฃฝ้ ;; ่ผธๅ ฅ
Dates and Status
Mar 06, 2024
Mar 06, 2029