Taiwan FDA registration 955d99b12182b1536d9c5be77e33025a
Reagent for measles IgG antibody test – quality control solution
TW: 禮雅尚麻疹IgG抗體檢驗試劑–品管液
Registration details
- Analysis ID
- 955d99b12182b1536d9c5be77e33025a
- Customs Code
- DHA05603568301
Company information
- Manufacturer
- DIASORIN ITALIA S.P.A.
- Manufacturer Country
- Italy
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- This product uses Reasan Chemiluminescence Immunoassay (CLIA) as a measles IgG antibody test reagent for reliability monitoring in the instrument platform testing of Reasan Analyzer, Reasan XL Analyzer, and Reasan 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
- Jul 20, 2022
- Expiry Date
- Jul 20, 2027
About this record
Access comprehensive regulatory information for Reagent for measles IgG antibody test – 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 955d99b12182b1536d9c5be77e33025a and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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