Taiwan FDA registration 57adc3fbd6ff625c4e9b9acab2720777
Synagosin I test reagent
TW: 快得利 揣耶濟 肌鈣蛋白I檢驗試劑
Taiwan·Risk Class 2·Quidel Cardiovascular Inc.·Registered Apr 19, 2016 – Apr 19, 2026ExpiredRegistration details
- Analysis ID
- 57adc3fbd6ff625c4e9b9acab2720777
- Customs Code
- DHA05602840607
Company information
- Manufacturer
- Quidel Cardiovascular Inc.
- Manufacturer Country
- United States
- Authorized Representative
- BIO-CHECK LABORATORIES LTD.
Product details
- Intended Use
- This reagent was used by immunofluorescence analysis and Alere Triage MeterPro instrument to rapidly quantify the content of Troponin I in whole blood and plasma samples after EDTA anticoagulation.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme test system; A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- import
Dates and status
- Registration Date
- Apr 19, 2016
- Expiry Date
- Apr 19, 2026
About this record
Access comprehensive regulatory information for Synagosin I test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 57adc3fbd6ff625c4e9b9acab2720777 and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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