Taiwan FDA registration 9106e24ae2c89735e1fd249e05092a24
Reich German Measles IgG second-generation antibody test group
TW: 禮雅尚德國麻疹IgG第二代抗體檢驗試劑組
Registration details
- Analysis ID
- 9106e24ae2c89735e1fd249e05092a24
- Customs Code
- DHA05603353206
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 WITH LIAISON ANALYZERS (LIAISON AND LIAISON XL) TO QUANTITATIVELY DETERMINE THE SPECIFIC IgG antibodies of german measles virus in human serum or plasma samples by chemical cold light immunoassay (clia) technology.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); C.3510 Serologic test for German measles virus
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 19, 2020
- Expiry Date
- Aug 19, 2025
About this record
Access comprehensive regulatory information for Reich German Measles IgG second-generation antibody test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9106e24ae2c89735e1fd249e05092a24 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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