Taiwan FDA registration 17a0b25fff46b14be097ac7ca8fda037
"Sudi" Pyrrhine Influenza Virus Antigen Rapid Test Reagent (Unsterilized)
TW: "速帝" 百而靈 流行性感冒病毒抗原快速檢驗試劑(未滅菌)
Registration details
- Analysis ID
- 17a0b25fff46b14be097ac7ca8fda037
- Customs Code
- DHA04401129408
Company information
- Manufacturer
- STANDARD DIAGNOSTICS, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
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
- Product Type (Level 2)
- C.3330 流感病毒血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Jan 13, 2012
- Expiry Date
- Jan 13, 2022
- Cancellation Date
- Apr 12, 2024
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Sudi" Pyrrhine Influenza Virus Antigen Rapid Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 17a0b25fff46b14be097ac7ca8fda037 and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
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