Taiwan FDA registration d03321b1b8c0663e50eb305cfee80614
"Abon" single-step rotavirus (feces) antigen rapid test (unsterilized)
TW: “艾邦”單一步驟輪狀病毒(糞便)抗原快速檢測試劑(未滅菌)
Registration details
- Analysis ID
- d03321b1b8c0663e50eb305cfee80614
- Customs Code
- DHA04600157105
Company information
- Manufacturer
- ABON BIOPHARM (HANGZHOU) CO., LTD
- Manufacturer Country
- China
- 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 "Polio Virus Serological Reagent (C.3405)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3405 Poliomyelitis virus serum reagent
- Import Information
- Chinese goods;; input
Dates and status
- Registration Date
- Jan 16, 2012
- Expiry Date
- Jan 16, 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 "Abon" single-step rotavirus (feces) antigen rapid test (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d03321b1b8c0663e50eb305cfee80614 and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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