Taiwan FDA registration cd80263525a5b8e2fd295797f5eec255

"APEP" home coronavirus antigen test kit

TW: "亞培" 家用新冠病毒抗原檢測套組

Taiwan·Risk Class 3·Abbott Rapid Diagnostics Jena GmbH;; ABBOTT DIAGNOSTICS KOREA INC.·Registered Feb 27, 2024 – Feb 27, 2029Active

Registration details

Analysis ID: cd80263525a5b8e2fd295797f5eec255
Customs Code: DHA05603706406

Company information

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

Product details

Intended Use: This product is a single-use in vitro rapid immunoassay with visually readable results, which is suitable for patients with COVID-19 symptoms to use nasal swab samples for qualitative detection of new coronavirus nucleocapsid protein antigen. This product is designed to allow untrained users to self-test and can be operated manually. A positive result cannot rule out the possibility of bacterial or other virus co-infection, and a negative result cannot completely rule out the possibility of new coronavirus infection, and the test result of this product cannot be used as the sole basis for diagnosis.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: 委託製造;; 輸入;; QMS/QSD

Dates and status

Registration Date: Feb 27, 2024
Expiry Date: Feb 27, 2029

About this record

Access comprehensive regulatory information for "APEP" home coronavirus antigen test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number cd80263525a5b8e2fd295797f5eec255 and manufactured by Abbott Rapid Diagnostics Jena GmbH;; ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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