Taiwan FDA registration 089c98a1349014df3363888daa8a75f5

Regal Mumps IgG antibody test reagent-quality control solution

TW: 禮雅尚腮腺炎 IgG抗體檢驗試劑-品管液

Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Aug 18, 2022 – Aug 18, 2027Active

Registration details

Analysis ID: 089c98a1349014df3363888daa8a75f5
Customs Code: DHA05603569202

Company information

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

Product details

Intended Use: This product is used by Reashang Chemiluminescence Immunoassay (CLIA), which is used in the instrument of Reasan XL Analyzer and Reap Shang XS Analyzer as a test reliability monitoring for Reap Shang parotitis IgG antibody test reagent.
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: Aug 18, 2022
Expiry Date: Aug 18, 2027

About this record

Access comprehensive regulatory information for Regal Mumps IgG 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 089c98a1349014df3363888daa8a75f5 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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