Taiwan FDA registration 0379f9578f207987a5cd5832034a51dd
"FilmArray" RP2/RP2 plus Control Panel (Non-Sterile)
TW: "菲瑞" 呼吸道病原體多標的核酸檢測二代品管套組 (未滅菌)
Taiwan·Risk Class 1·MD·Maine Molecular Quality Controls, Inc.·Registered Mar 09, 2020 – Mar 09, 2025ExpiredRegistration details
- Analysis ID
- 0379f9578f207987a5cd5832034a51dd
- License Form
- Ministry of Health Medical Device Import No. 021349
- Customs Code
- DHA09402134906
Company information
- Manufacturer
- Maine Molecular Quality Controls, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- MEDTRI 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
- Mar 09, 2020
- Expiry Date
- Mar 09, 2025
About this record
Access comprehensive regulatory information for "FilmArray" RP2/RP2 plus Control Panel (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 0379f9578f207987a5cd5832034a51dd and manufactured by Maine Molecular Quality Controls, Inc.. The authorized representative in Taiwan is MEDTRI CO., LTD..
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