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
Taiwan flagTaiwan·Risk Class 2·MINARIS MEDICAL AMERICA, INC.·Registered Dec 08, 2010 – Dec 08, 2025Expired
Registration details
Analysis ID
651862d3bf1e5ace128537d12ee074b7
Customs Code
DHA00602192200
Company information
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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