Taiwan FDA registration eb99f1255a4c2c6e24641aeb7d9e94c7

Liyashang EBV Capsid Antigen IgM Detection Reagent - Quality Control Solution

TW: 禮雅尚EB病毒殼抗原IgM檢測試劑-品管液

Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Sep 22, 2023 – Sep 22, 2028Active

Registration details

Analysis ID: eb99f1255a4c2c6e24641aeb7d9e94c7
Customs Code: DHA05603622308

Company information

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

Product details

Intended Use: This product uses CLIA chemiluminescence immunoassay (CLIA) as a test reliability of the Leygo EBV shell antigen immunoglobulin M detection reagent in the Leysandr XL analyzer and the Leysandar 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: Input;; QMS/QSD

Dates and status

Registration Date: Sep 22, 2023
Expiry Date: Sep 22, 2028

About this record

Access comprehensive regulatory information for Liyashang EBV Capsid Antigen IgM 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 eb99f1255a4c2c6e24641aeb7d9e94c7 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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