Taiwan FDA registration 28b0cad5496af4c420b5e96f68fe94a4

"Abbot" Rapid Test Reagent for Influenza Virus Antigen

TW: “亞培” 百而靈流感病毒抗原快速檢驗試劑

Taiwan·Risk Class 2·ABBOTT DIAGNOSTICS KOREA INC.·Registered Aug 28, 2020 – Aug 28, 2025Expired

Registration details

Analysis ID: 28b0cad5496af4c420b5e96f68fe94a4
Customs Code: DHA05603354502

Company information

Manufacturer: ABBOTT DIAGNOSTICS KOREA INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3328 Influenza Virus Antigen Rapid Screening and Detection System
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 28, 2020
Expiry Date: Aug 28, 2025

About this record

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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