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Reagent for anti-hepatitis A virus antibody test - Taiwan Registration 93ca1dd6bf8e4ec82053ed40050251de

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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93ca1dd6bf8e4ec82053ed40050251de
Registration Details
Taiwan FDA Registration: 93ca1dd6bf8e4ec82053ed40050251de
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Device Details

Reagent for anti-hepatitis A virus antibody test
TW: ็ฆฎ้›…ๅฐšๆŠ—Aๅž‹่‚็‚Ž็—…ๆฏ’ๆŠ—้ซ”ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 3

Registration Details

93ca1dd6bf8e4ec82053ed40050251de

DHA05603348500

Company Information

Italy

Product Details

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.

B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); B.4020 Analysis of specific tests

import

Dates and Status

May 18, 2020

May 18, 2025