Taiwan FDA registration 33a22878a18255749441ebf58a54d600

Roche novel coronavirus and influenza A/B virus rapid antigen test reagent

TW: 羅氏新型冠狀病毒及 A/B 型流感病毒快速抗原檢驗試劑

Taiwan·Risk Class 3·SD BIOSENSOR, INC.·Registered Feb 15, 2024 – Feb 15, 2029Active

Registration details

Analysis ID: 33a22878a18255749441ebf58a54d600
Customs Code: DHA05603706001

Company information

Manufacturer: SD BIOSENSOR, INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product is a rapid immunochromatography assay that can simultaneously qualitatively detect and distinguish the novel coronavirus nucleocapsid protein and influenza A virus and influenza B virus antigens present in human nasopharyngeal swab specimens. This product has not been tested for suitability for the identification of type A, H5 and H7 subtypes.
Product Type (Level 1): B Hematology, Pathology and Genetics;; A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); C.3328 Influenza Virus Antigen Rapid Test System;; B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Feb 15, 2024
Expiry Date: Feb 15, 2029

About this record

Access comprehensive regulatory information for Roche novel coronavirus and influenza A/B virus rapid antigen test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 33a22878a18255749441ebf58a54d600 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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