Taiwan FDA registration f4cfc7204d0e9b7a9f97add64f90f48a
FilmArray Pneumonia/Pneumoniaplus Control (Non-sterile)
TW: 微晶肺炎品管試劑套組(未滅菌)
Registration details
- Analysis ID
- f4cfc7204d0e9b7a9f97add64f90f48a
- License Form
- Ministry of Health Medical Device Import No. 020833
- Customs Code
- DHA09402083306
Company information
- Manufacturer
- Maine Molecular Quality Controls, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of quality control materials (analytical and non-analytical) (A.1660) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 06, 2019
- Expiry Date
- Sep 06, 2024
About this record
Access comprehensive regulatory information for FilmArray Pneumonia/Pneumoniaplus Control (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f4cfc7204d0e9b7a9f97add64f90f48a and manufactured by Maine Molecular Quality Controls, Inc.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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