Taiwan FDA registration 9c054e7c6eca4a4a265e910bd6b056ba
Quidel Triage Total 3 Control
TW: 快得利揣耶濟心臟檢驗品管試劑
Registration details
- Analysis ID
- 9c054e7c6eca4a4a265e910bd6b056ba
- License Form
- Ministry of Health Medical Device Import No. 028416
- Customs Code
- DHA05602841600
Company information
- Manufacturer
- Quidel Cardiovascular Inc.
- Manufacturer Country
- United States
- Authorized Representative
- BIO-CHECK LABORATORIES LTD.
Product details
- Intended Use
- This product is a known concentration of the test substance that can be used in devices such as Alere Triage Troponin I Test, Alere Triage BNP Test, Alere Triage Cardio2 Panel and Alere Triage Cardio3 Panel, as well as Ariel Hydra Analyzer to assist users in monitoring product performance.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 28, 2016
- Expiry Date
- Apr 28, 2026
About this record
Access comprehensive regulatory information for Quidel Triage Total 3 Control in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9c054e7c6eca4a4a265e910bd6b056ba and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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