Taiwan FDA registration 60badc830092eba9ffc2746ef10a2513
“Abbott” Bioline Dengue NS1 Ag ELISA
TW: “亞培” 百而靈登革熱NS1抗原檢驗試劑
Taiwan·Risk Class 2·MD·ABBOTT DIAGNOSTICS KOREA INC.·Registered Jun 15, 2017 – Jun 15, 2027ActiveRegistration details
- Analysis ID
- 60badc830092eba9ffc2746ef10a2513
- License Form
- Ministry of Health Medical Device Import No. 029579
- Customs Code
- DHA05602957904
Company information
- Manufacturer
- ABBOTT DIAGNOSTICS KOREA INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- This product uses enzyme-linked immunosorbent assay to qualitatively detect dengue NS1 antigen in human serum.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C0002 Dengue virus serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 15, 2017
- Expiry Date
- Jun 15, 2027
About this record
Access comprehensive regulatory information for “Abbott” Bioline Dengue NS1 Ag ELISA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 60badc830092eba9ffc2746ef10a2513 and manufactured by ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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