Taiwan FDA registration 1057678ae4499ee9a1cacc029863b5bb
QuickProfit Heart 2-in-1 Test Reagent
TW: 快得利 揣耶濟 心臟二合一檢驗試劑
Taiwan·Risk Class 2·Quidel Cardiovascular Inc.·Registered Apr 19, 2016 – Apr 19, 2026ExpiredRegistration details
- Analysis ID
- 1057678ae4499ee9a1cacc029863b5bb
- Customs Code
- DHA05602840709
Company information
- Manufacturer
- Quidel Cardiovascular Inc.
- Manufacturer Country
- United States
- Authorized Representative
- BIO-CHECK LABORATORIES LTD.
Product details
- Intended Use
- This reagent is used in conjunction with the Alere Triage MeterPro analyzer for immunofluorescence analysis, which can quickly and quantitatively detect the content of troponin I and B-type natriuretic peptide in whole blood and plasma samples treated with EDTA anticoagulation.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1117 Type B Natriuretic Peptide Test System;; A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing 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 QuickProfit Heart 2-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 1057678ae4499ee9a1cacc029863b5bb and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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