Taiwan FDA registration af26731bf99b8cb078affb7383443888

Reeks Mumps IgM antibody test reagent-quality control solution

TW: 禮雅尚腮腺炎 IgM抗體檢驗試劑-品管液

Taiwan·Risk Class 2·DiaSorin Italia SpA·Registered Mar 14, 2023 – Mar 14, 2028Active

Registration details

Analysis ID: af26731bf99b8cb078affb7383443888
Customs Code: DHA05603616102

Company information

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

Product details

Intended Use: This product uses Reasan Chemiluminescence Immunoassay (CLIA) as a reagent for the reliability of Reasan parotitis IgM antibody test in the instrument platform testing of Reap Shang Analyzer, Releg Shang XL Analyzer and Reasun 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: Mar 14, 2023
Expiry Date: Mar 14, 2028

About this record

Access comprehensive regulatory information for Reeks Mumps IgM antibody test 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 af26731bf99b8cb078affb7383443888 and manufactured by DiaSorin Italia SpA. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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