Sekisui Diagnostics announces the authorization of the FDA for its Sekure® HBA1C essay.The test has been authorized to contribute to the diagnosis of diabetes mellitus and the identification of patients at risk of diabetes mellitus and to supervise long -term glucose control in people with diabetes mellitus.
The A1C (HBA1C) hemoglobin test is the most used in the diagnosis and monitoring of diabetes, a condition that affects more than 30 million people in the US. UU. And 425 million people in the world.One in 4 people in the US. He does not know that he suffers from diabetes, so diagnosis and handling are important to slow down the disease and its associated side effects.(1)
Sekure® HBA1C test is used in clinical laboratories to measure the HBA1C concentration percentage (NGSP) or the HBA1C fraction in mmol/mol (IFCC) in total human and hemolyzed venous blood.It is an enzymatic test certified by NGSP that uses a pretreatment step integrated to the SK clinical chemistry system (TM) 500 of Sekisui Diagnostics to eliminate the tedious manual preparation before the test.With the authorization of the FDA, the Sekure® HBA1C test is now available in the SK500 system both in the US and in the European Union, since it previously obtained the CE marking.
"We are very excited about the announcement of the authorization of the Sekure® HBA1C essay, which expands the SK500 clinical chemistry system and provides a valuable offer to low -to -moderate volume laboratories that they want to automate the HBA1C tests in their system of their system ofClinical Chemistry, "said Robert Schruender, president and CEO of Sekisui Diagnostics."This system is largely complemented by the rest of our line of clinical chemistry products and demonstrates our commitment to the development of innovative products that improve patients' care."
About Sekisui Diagnostics:
Sekisui Diagnostics is a global diagnostic company committed to improving patients' lives by supplying innovative medical diagnostic systems to doctors and laboratories through a world commercial network.Product lines include clinical chemistry and coagulation systems, reagents, rapid test kits, immunoassay and molecular systems for use in sanitary facilities, as well as enzymes and specialized biochemical products.
Sekure is a registered trademark of Sekisui Diagnostics, LLC.B out