Taiwan FDA registration 8e9ea3bb7459a5a553af89900f468424
Abotroponin I assay (whole blood/serum/plasma)
TW: 艾博肌鈣蛋白I檢測試劑(全血/血清/血漿)
Taiwan·Risk Class 2·ABON BIOPHARM (HANGZHOU) CO., LTD·Registered Oct 15, 2007 – Oct 15, 2022CancelledRegistration details
- Analysis ID
- 8e9ea3bb7459a5a553af89900f468424
- Customs Code
- DHA04200034205
Company information
- Manufacturer
- ABON BIOPHARM (HANGZHOU) CO., LTD
- Manufacturer Country
- China
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Human cardiac troponin I was qualitatively detected in clinical specimens (whole blood/serum/plasma) using immunochromatographic analysis.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
- Import Information
- Chinese goods;; input
Dates and status
- Registration Date
- Oct 15, 2007
- Expiry Date
- Oct 15, 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 Abotroponin I assay (whole blood/serum/plasma) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8e9ea3bb7459a5a553af89900f468424 and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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