IB10 sphingotest® PCT
IB10 sphingotest® PCT, is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Procalcitonin (PCT) in the concentration range of 0.3 µg/L to 10.00 µg/L in EDTA whole blood and plasma. This assay is only intended for the diagnosis of sepsis, the assessment of the degree of severity, and monitoring of the change of sepsis severity. This assay is neither suitable nor intended for other applications and/or uses. This test 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. The IB10 sphingotest® PCT is intended for use in conjunction with the Nexus IB10 Analyzer and provides quantitative results in 20 minutes
Products based on the Nexus IB10 technology (Nexus Dx, Inc., 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 Nexus IB10 technology as in vitro diagnostic (IVD) product in the United States of America or Canada. No product based on the Nexus 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 Nexus IB10 product may be sold at some future point in time in the U.S., have not yet been established.