Taiwan FDA registration 430a012951c26b35d43934b7b4297d5a
"Minaris" OPTIGEN AP 720S Semi-Automated Instrument
TW: "梅納麗斯" 歐特敏過敏原特異性IgE診斷試劑半自動分析儀
Taiwan·Risk Class 2·MD·MINARIS MEDICAL AMERICA, INC.·Registered May 05, 2014 – May 05, 2024ExpiredRegistration details
- Analysis ID
- 430a012951c26b35d43934b7b4297d5a
- License Form
- Ministry of Health Medical Device Import No. 026079
- Customs Code
- DHA05602607908
Company information
- Manufacturer
- MINARIS MEDICAL AMERICA, INC.
- Manufacturer Country
- United States
- Authorized Representative
- MED PHAR ENTERPRISE CO., LTD.
Product details
- Intended Use
- Combined with "Hitachi" Otemin allergen-specific IgE diagnostic reagent, it is used to semi-quantitatively measure the concentration of allergen-specific IgE in human serum.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5750 Radioactive Allergen Adsorption Immunoassay System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 05, 2014
- Expiry Date
- May 05, 2024
About this record
Access comprehensive regulatory information for "Minaris" OPTIGEN AP 720S Semi-Automated Instrument in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 430a012951c26b35d43934b7b4297d5a and manufactured by MINARIS MEDICAL AMERICA, INC.. The authorized representative in Taiwan is MED PHAR ENTERPRISE CO., LTD..
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