Taiwan FDA registration bc8508d1456f7cea31007aeb65ceb970
“RapiGEN” Influenza A＆B Ag (Non-Sterile)
TW: “睿軍”流感病毒A＆B抗原快速檢驗試劑(未滅菌)
Taiwan·Risk Class 1·MD·RAPIGEN INC.·Registered Nov 30, 2017 – Nov 30, 2022ExpiredRegistration details
- Analysis ID
- bc8508d1456f7cea31007aeb65ceb970
- License Form
- Ministry of Health Medical Device Import No. 018559
- Customs Code
- DHA09401855907
Company information
- Manufacturer
- RAPIGEN INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Medley Limited
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Influenza Virus Serum Reagent (C.3330)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3330 Influenza virus serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 30, 2017
- Expiry Date
- Nov 30, 2022
About this record
Access comprehensive regulatory information for “RapiGEN” Influenza A＆B Ag (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 bc8508d1456f7cea31007aeb65ceb970 and manufactured by RAPIGEN INC.. The authorized representative in Taiwan is Medley Limited.
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