IB10 Biorigins® D-Dimer


 Item Number : 050-00070
MOQ (Discs) : 2000

10 in stock

SKU: IVR-IB52 Category:


IB10 Biorigins® D-Dimer, is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of cross-linked fibrin degradation products containing D-dimer, in human whole blood or plasma, using lithium heparin or sodium citrate as the anticoagulant. The D-Dimer Test is intended for use in conjunction with the IB10 Analyzer and provides quantitative results in 20 minutes.

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. D-dimer determinations aid in the quantitative assessment and evaluation of patients presenting with clinical symptoms of Venous Thromboembolism (VTE) including severely evolving Disseminated Intravascular Coagulation (DIC), pulmonary embolism (PE) and deep vein thrombosis (DVT). Values at or below the upper limit of a healthy reference population are highly predictive of exclusion of VTE as a cause of symptoms.


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.

  1. “Products and Price List” of the Supply and Service Agreement.
  2. Defined terms used herein and not otherwise defined shall have the meanings given to them in the Agreement.
  3. All unmodified and remaining terms and conditions of the Agreement are hereby ratified and confirmed and shall remain in full force and effect.
  4. This agreement shall be governed by and construed in accordance with the laws of the (Name of Country), without regard to the principles of conflict of laws.

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