Taiwan FDA registration 8f8daaea14373bf1dc1c89a3e1d882a3
Otemine allergen-specific IgE diagnostic reagent
TW: 歐特敏過敏原特異性IgE診斷試劑
Taiwan·Risk Class 2·MINARIS MEDICAL AMERICA, INC.·Registered Oct 19, 2007 – Oct 19, 2027ActiveRegistration details
- Analysis ID
- 8f8daaea14373bf1dc1c89a3e1d882a3
- Customs Code
- DHA00601864602
Company information
- Manufacturer
- MINARIS MEDICAL AMERICA, INC.
- Manufacturer Country
- United States
- Authorized Representative
- MED PHAR ENTERPRISE CO., LTD.
Product details
- Intended Use
- OPTIGEN TM diagnostic reagent is an in vitro semi-quantitative test for allergen-specific IgE concentrations in human serum.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5750 Radioallergen adsorption immunoassay system
- Import Information
- import
Dates and status
- Registration Date
- Oct 19, 2007
- Expiry Date
- Oct 19, 2027
About this record
Access comprehensive regulatory information for Otemine allergen-specific IgE diagnostic reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8f8daaea14373bf1dc1c89a3e1d882a3 and manufactured by MINARIS MEDICAL AMERICA, INC.. The authorized representative in Taiwan is MED PHAR ENTERPRISE CO., LTD..
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