Description
IB10 Biorigins® 3-in-1 Cardiac, is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Cardiac Troponin I (cTnI), CK-MB and Myoglobin, in lithium heparin whole blood and plasma. This Test is intended for use in conjunction with the IB10 Analyzer and provides quantitative results in 20 minutes.
The IB10 Biorigins® 3-in-1 Cardiac is designed for professional use only and may be used in hospital central laboratories and in alternate care settings such as emergency departments, critical care units, and other sites where near patient testing is practiced.
Disclaimer:
Products based on the IB10 technology (San Diego, CA, USA) described are CE-IVD-marked and hence certified and approved for use in the European Economic Area (EEA) only. Human diagnostic use of such products may be subject to local regulations.
Caution – The information contained in this communication does not constitute nor imply an offer to sell or transfer any product based on the IB10 technology as in vitro diagnostic (IVD) product in the United States of America or Canada. No product based on the IB10 technology is currently available for sale as an IVD product in the United States of America or Canada. The analytical and clinical performance characteristics in compliance with U.S. FDA medical device regulations of any IB10 product may be sold at some future point in time in the U.S., have not yet been established.
Product is sold only in Africa.
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