Taiwan FDA registration 99cc9cce45d7236fe4b9173fbd5461e3
禮雅尚EB病毒核抗原 IgG 檢測試劑-品管液
Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Feb 22, 2024 – Feb 22, 2029ActiveRegistration details
- Analysis ID
- 99cc9cce45d7236fe4b9173fbd5461e3
- Customs Code
- DHA05603706202
Company information
- Manufacturer
- DIASORIN ITALIA S.P.A.
- Manufacturer Country
- Italy
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- This product is tested by CLIA Chemiluminescence Immunoassay (CLIA) as a reagent for EBV nuclear antigen IgG detection in the Leyson XL Analyzer and the LeyElegance 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
- Feb 22, 2024
- Expiry Date
- Feb 22, 2029
About this record
Access comprehensive regulatory information for 禮雅尚EB病毒核抗原 IgG 檢測試劑-品管液 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 99cc9cce45d7236fe4b9173fbd5461e3 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices