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Regal Shang EB Virus Shell Antigen IgG Detection Reagent - Quality Control Solution - Taiwan Registration 5a82c0371816cf1aa21570a5cf888d2e

Access comprehensive regulatory information for Regal Shang EB Virus Shell Antigen IgG Detection Reagent - Quality Control Solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5a82c0371816cf1aa21570a5cf888d2e and manufactured by DiaSorin Italia SpA. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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5a82c0371816cf1aa21570a5cf888d2e
Registration Details
Taiwan FDA Registration: 5a82c0371816cf1aa21570a5cf888d2e
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Device Details

Regal Shang EB Virus Shell Antigen IgG Detection Reagent - Quality Control Solution
TW: ็ฆฎ้›…ๅฐš EB ็—…ๆฏ’ๆฎผๆŠ—ๅŽŸ IgGๆชขๆธฌ่ฉฆๅŠ‘-ๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

5a82c0371816cf1aa21570a5cf888d2e

DHA05603620404

Company Information

Italy

Product Details

This product is based on Reasan Chemiluminescence Immunoassay (CLIA) as a reagent for the detection of Rayasan EB virus shell antigen IgG in the instrument platform of Reasan XL Analyzer and Reap Shang XS Analyzer.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Jul 26, 2023

Jul 26, 2028