Taiwan FDA registration a8a3114de4990796b93090fbb6c93762
"HealthYou" Anti-EBV test kit (Non-Sterile)
TW: "信義興" EB病毒抗體試劑套組 (未滅菌)
Registration details
- Analysis ID
- a8a3114de4990796b93090fbb6c93762
- License Form
- Ministry of Health Medical Device Import No. 017075
- Customs Code
- DHA09401707506
Company information
- Manufacturer
- FULLER LABORATORIES
- Manufacturer Country
- United States
- Authorized Representative
- HEALTHYOU CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of "Epstein-Barr virus serum reagent (C.3235)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3235 Epstein-Barr virus serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 13, 2016
- Expiry Date
- Oct 13, 2021
About this record
Access comprehensive regulatory information for "HealthYou" Anti-EBV test kit (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 a8a3114de4990796b93090fbb6c93762 and manufactured by FULLER LABORATORIES. The authorized representative in Taiwan is HEALTHYOU CO., LTD..
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