Taiwan FDA registration c06cc7845287f86c38814d6af8f60f69
Rapid test tablets for Dengue Fever
TW: 速得百森登革熱NS1抗原快速測試片
Taiwan·Risk Class 2·SD BIOSENSOR, INC.·Registered Mar 07, 2022 – Mar 07, 2027ActiveRegistration details
- Analysis ID
- c06cc7845287f86c38814d6af8f60f69
- Customs Code
- DHA05603522405
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- CREATIVE LIFE SCIENCE CO., LTD.
Product details
- Intended Use
- This product is used by immunofluorescence analysis with STANDARD F200 analyzer to detect dengue virus NS1 antigen in human serum and plasma. This test is used for in vitro professional diagnosis and assistance in the early diagnosis of dengue virus infection.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0002 登革熱病毒血清試劑
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Mar 07, 2022
- Expiry Date
- Mar 07, 2027
About this record
Access comprehensive regulatory information for Rapid test tablets for Dengue Fever in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c06cc7845287f86c38814d6af8f60f69 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is CREATIVE LIFE SCIENCE CO., LTD..
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