Taiwan FDA registration 157dac7f2e825165e117eb2e5a4fcc6f

"Apei" new coronavirus antigen rapid test kit

TW: "亞培" 新冠病毒抗原快速檢測套組

Taiwan·Risk Class 3·Abbott Rapid Diagnostics Jena GmbH;; ABBOTT DIAGNOSTICS KOREA INC.·Registered Mar 06, 2024 – Mar 06, 2029Active

Registration details

Analysis ID: 157dac7f2e825165e117eb2e5a4fcc6f
Customs Code: DHA05603706600

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 rapid test for in vitro diagnostics for the qualitative detection of the new coronavirus nucleocapsid protein antigen in nasal swabs or nasopharyngeal samples of patients with COVID-19 symptoms. This product is intended for use by professionals only. 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: QMS/QSD;; 委託製造;; 輸入

Dates and status

Registration Date: Mar 06, 2024
Expiry Date: Mar 06, 2029

About this record

Access comprehensive regulatory information for "Apei" new coronavirus antigen rapid 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 157dac7f2e825165e117eb2e5a4fcc6f 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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