“Abbott” Bioline Dengue IgG Capture ELISA - Taiwan Registration 7ce56c742ba2c82e0e37e861f417ea37
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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Device Details
Registration Details
7ce56c742ba2c82e0e37e861f417ea37
Ministry of Health Medical Device Import No. 027355
DHA05602735501
Product Details
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.
C Immunology and microbiology devices
C0002 Dengue virus serum reagent
Imported from abroad
Dates and Status
Jun 22, 2015
Jun 22, 2025