Taiwan FDA registration 7ce56c742ba2c82e0e37e861f417ea37
“Abbott” Bioline Dengue IgG Capture ELISA
TW: “亞培” 百而靈登革熱免疫球蛋白G檢驗試劑
Taiwan·Risk Class 2·MD·ABBOTT DIAGNOSTICS KOREA INC.·Registered Jun 22, 2015 – Jun 22, 2025ExpiredRegistration details
- Analysis ID
- 7ce56c742ba2c82e0e37e861f417ea37
- License Form
- Ministry of Health Medical Device Import No. 027355
- Customs Code
- DHA05602735501
Company information
- Manufacturer
- ABBOTT DIAGNOSTICS KOREA INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- The Speedi dengue immunoglobulin G assay was used by enzyme immunosorbent method to qualitatively detect IgG antibodies to dengue virus in human serum. This test is intended for use by professionals only and can assist in the diagnosis of dengue virus infection. Positive subjects should be confirmed by methods such as RT-PCR and gold-standard HAI (blood agglutination inhibition) tests.
- 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 22, 2015
- Expiry Date
- Jun 22, 2025
About this record
Access comprehensive regulatory information for “Abbott” Bioline Dengue IgG Capture ELISA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7ce56c742ba2c82e0e37e861f417ea37 and manufactured by ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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