"Abbot" Rapid Test Reagent for Influenza Virus Antigen - Taiwan Registration 28b0cad5496af4c420b5e96f68fe94a4
Access comprehensive regulatory information for "Abbot" Rapid Test Reagent for Influenza Virus Antigen in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 28b0cad5496af4c420b5e96f68fe94a4 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
28b0cad5496af4c420b5e96f68fe94a4
DHA05603354502
Product Details
This product is an immunochromatography method that can be used for differential and qualitative detection of influenza A and B antigens directly from nasopharyngeal swabs or nasopharyngeal extracts. This product is not intended for the detection of influenza C virus antigen. This product is intended for use by professionals performing in vitro diagnostics only.
C Immunology and microbiology
C.3328 Influenza Virus Antigen Rapid Screening and Detection System
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Aug 28, 2020
Aug 28, 2025