Taiwan FDA registration e0d18e96457c541ba1e6b78e71ed4115
"Abbott" Platrin Dengue Dual Effect Dengue Antigen Antibody Rapid Test Piece.
TW: "亞培"百而靈登革熱雙效登革熱NS1抗原抗體快速測試片。
Registration details
- Analysis ID
- e0d18e96457c541ba1e6b78e71ed4115
- Customs Code
- DHA00602408500
Company information
- Manufacturer
- ABBOTT DIAGNOSTICS KOREA INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- The ratio of dengue virus NS1 antigen to IgG/IgM antibody in human serum, plasma and whole blood was simultaneously detected in a single step using in vitro immunochromography.
- 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
- import
Dates and status
- Registration Date
- Sep 28, 2012
- Expiry Date
- Sep 28, 2027
About this record
Access comprehensive regulatory information for "Abbott" Platrin Dengue Dual Effect Dengue Antigen Antibody Rapid Test Piece. in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e0d18e96457c541ba1e6b78e71ed4115 and manufactured by ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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