Taiwan FDA registration 5a82c0371816cf1aa21570a5cf888d2e

Regal Shang EB Virus Shell Antigen IgG Detection Reagent - Quality Control Solution

TW: 禮雅尚 EB 病毒殼抗原 IgG檢測試劑-品管液

Taiwan·Risk Class 2·DiaSorin Italia SpA·Registered Jul 26, 2023 – Jul 26, 2028Active

Registration details

Analysis ID: 5a82c0371816cf1aa21570a5cf888d2e
Customs Code: DHA05603620404

Company information

Manufacturer: DiaSorin Italia SpA
Manufacturer Country: Italy
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Jul 26, 2023
Expiry Date: Jul 26, 2028

About this record

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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