Taiwan FDA registration 93ca1dd6bf8e4ec82053ed40050251de

Reagent for anti-hepatitis A virus antibody test

TW: 禮雅尚抗A型肝炎病毒抗體檢驗試劑

Taiwan·Risk Class 3·DIASORIN ITALIA S.P.A.·Registered May 18, 2020 – May 18, 2025Expired

Registration details

Analysis ID: 93ca1dd6bf8e4ec82053ed40050251de
Customs Code: DHA05603348500

Company information

Manufacturer: DIASORIN ITALIA S.P.A.
Manufacturer Country: Italy
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: This product is used with the Reasan Analyzer or the Reap XR Analyzer to qualitatively determine the total antibodies to hepatitis A virus (anti-hepatitis A virus) in human serological or plasma samples by chemical cold light immunoassay (CLIA) technology.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); B.4020 Analysis of specific tests
Import Information: import

Dates and status

Registration Date: May 18, 2020
Expiry Date: May 18, 2025

About this record

Access comprehensive regulatory information for Reagent for anti-hepatitis A virus antibody test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 93ca1dd6bf8e4ec82053ed40050251de and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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