Formosa Plastics Biomedicine Xunzhi Novel Coronavirus Antigen Rapid Test Reagent
Taiwan·Risk Class 3·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered Nov 08, 2023 – Nov 08, 2028Active- Analysis ID
- 365f92679d921d45a1a798ea22bd5b05
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Formosa Biomedical Technology Co., Ltd. Yilan Factory
- Intended Use
- This product is used to qualitatively detect the nucleoprotein of the novel coronavirus in the nasopharyngeal swab of patients with suspected symptoms of novel coronavirus pneumonia (COVID-19) in the acute infection stage of patients with suspected symptoms of novel coronavirus pneumonia (COVID-19). A positive result indicates the presence of viral antigens in the specimen, but must be combined with the patient's history and other clinical data to assess the status of infection; a positive result does not rule out bacterial infection or co-infection with other viruses, and the detected pathogen is not necessarily the primary cause of the disease. Negative results cannot completely rule out novel coronavirus pneumonia infection, so this product should not be used as the sole basis for treatment or management decisions including infection control, and negative results should be based on the patient's contact history, medical history, signs and clinical symptoms, and if necessary, the diagnosis should be confirmed by molecular diagnosis (RT-PCR), and used as the basis for patient management. This product is intended for professional use only.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- QMS/QSD;; 國產
- Registration Date
- Nov 08, 2023
- Expiry Date
- Nov 08, 2028
Access comprehensive regulatory information for Formosa Plastics Biomedicine Xunzhi Novel Coronavirus Antigen Rapid 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 365f92679d921d45a1a798ea22bd5b05 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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