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"Abbott" drops acquired immunodeficiency virus two-in-one test strip - Taiwan Registration 1665c67591119e309e42b8eeeedb1038

Access comprehensive regulatory information for "Abbott" drops acquired immunodeficiency virus two-in-one test strip in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 1665c67591119e309e42b8eeeedb1038 and manufactured by ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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1665c67591119e309e42b8eeeedb1038
Registration Details
Taiwan FDA Registration: 1665c67591119e309e42b8eeeedb1038
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Device Details

"Abbott" drops acquired immunodeficiency virus two-in-one test strip
TW: โ€œไบžๅŸนโ€ ๆปดๅฐฑ้ˆๅพŒๅคฉๅ…็–ซไธๅ…จ็—…ๆฏ’ไบŒๅˆไธ€ๆชข้ฉ—่ฉฆ็ด™
Risk Class 3

Registration Details

1665c67591119e309e42b8eeeedb1038

DHA05603491106

Company Information

Product Details

This product is an in vitro, visually interpretable and qualitative immunoassay that simultaneously detects HIV-1 and HIV-2 antibodies (Ab) and non-immune complex (free) HIV-1 p24 antigen (Ag) in human fingertip microvascular and venous whole blood, plasma or serum.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

Input;; QMS/QSD

Dates and Status

Oct 08, 2021

Oct 08, 2026