Taiwan FDA registration 4a7791e1a15ca6064964a4f24f4f70fd
QuickProfit Yazi Heart 3-in-1 test reagent
TW: 快得利 揣耶濟 心臟三合一檢驗試劑
Taiwan·Risk Class 2·Quidel Cardiovascular Inc.·Registered Apr 25, 2016 – Apr 25, 2026ExpiredRegistration details
- Analysis ID
- 4a7791e1a15ca6064964a4f24f4f70fd
- Customs Code
- DHA05602841001
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 contents of Creatine Kinase MB, Troponin I., and B-type Natriuretic Peptide in whole blood and plasma samples after EDTA anticoagulation.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; A.1117 B type B natriuretic peptide test system
- Import Information
- import
Dates and status
- Registration Date
- Apr 25, 2016
- Expiry Date
- Apr 25, 2026
About this record
Access comprehensive regulatory information for QuickProfit Yazi Heart 3-in-1 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 4a7791e1a15ca6064964a4f24f4f70fd and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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