Taiwan FDA registration 651862d3bf1e5ace128537d12ee074b7
"Menaris" Otemin allergen-specific IgE diagnostic reagent
TW: “梅納麗斯”歐特敏 過敏原特異性IgE診斷試劑
Registration details
- Analysis ID
- 651862d3bf1e5ace128537d12ee074b7
- Customs Code
- DHA00602192200
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 used for in vitro semi-quantitative testing of 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
- Dec 08, 2010
- Expiry Date
- Dec 08, 2025
About this record
Access comprehensive regulatory information for "Menaris" Otemin 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 651862d3bf1e5ace128537d12ee074b7 and manufactured by MINARIS MEDICAL AMERICA, INC.. The authorized representative in Taiwan is MED PHAR ENTERPRISE CO., LTD..
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