Formosa Plastics Biomedical Novel Coronavirus Antigen Rapid Test Reagent for Home Use - Taiwan Registration 16bc3e61b1c7317438e914f5e140f408
Access comprehensive regulatory information for Formosa Plastics Biomedical Novel Coronavirus Antigen Rapid Test Reagent for Home Use in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 16bc3e61b1c7317438e914f5e140f408 and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is Formosa Biomedical Technology Co., Ltd. Yilan Factory.
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Device Details
Product Details
This product is used to qualitatively detect the nucleoprotein of the novel coronavirus in the nasal cavity of patients with suspected symptoms of novel coronavirus pneumonia (COVID-19) in the acute infection stage with suspected symptoms of novel coronavirus pneumonia (COVID-19). A positive result cannot rule out bacterial infection or co-infection with other viruses, and a negative result cannot completely rule out novel coronavirus pneumonia infection, and this product alone should not be used as the sole basis for treatment or management decisions including infection control.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
ๅ็ข;; QMS/QSD
Dates and Status
Dec 18, 2023
Dec 18, 2028