Sekisui Diagnostics Receives FDA Clearance for SEKURE HbA1c Assay

- Hemoglobin A1c (HbA1c) is the most commonly used test to help diagnose and monitor diabetes, a condition that affects over 30 million people in the US and 425 million worldwide. With 1 in 4 people in the US unaware they have diabetes, diagnosis and management are important in delaying the progression of disease and its associated side effects. 1

The SEKURE HbA1c assay is used in clinical laboratories to measure the percent concentration of HbA1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate.  It is an enzymatic assay which is NGSP certified and utilizes an onboard pretreatment step on Sekisui Diagnostics SK 500 Clinical Chemistry System, eliminating time-consuming manual preparation prior to testing.  With the FDA clearance, the SEKURE HbA1c test is now available on the SK500 in both the US as well as the European Union as it previously obtained a CE mark.

"We are very excited to announce the clearance of the SEKURE® HbA1c assay which expands the SK500 Clinical Chemistry System menu and brings a valuable offering to low-to-moderate volume laboratories seeking to automate HbA1c tests on their clinical chemistry system," said Robert Schruender, President & CEO of Sekisui Diagnostics. "This system is highly complementary with the rest of our clinical chemistry product line and illustrates our commitment to deliver innovative products which improve patient care."

About Sekisui Diagnostics:

Sekisui Diagnostics is a global diagnostics company committed to improving patient's lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network.  Product lines include clinical chemistry and coagulation systems, reagents, rapid test kits, point-of-care immunoassay and molecular systems as well as enzymes and specialty bio-chemicals.

1 https://www.cdc.gov/diabetes/basics/diabetes.html http://www.diabetesatlas.org/

SEKURE is a registered trademark of Sekisui Diagnostics, LLC.Because Every Result Matters is a trademark of Sekisui Diagnostics, LLC

Logo - https://mma.prnewswire.com/media/412597/sekisui_diagnostics_logo.jpg  


Condividi le tue opinioni su Il Tempo

Caratteri rimanenti: 1500


Gracia De Torres e Daniele Sandri: il nostro matrimonio gipsy bohemian [VIDEO]

Il Tricolore atterra sui Fori Imperiali: ecco il lancio mozzafiato del paracadutista della Folgore
Sul palco in bermuda, il balletto di Maradona per Maduro
Choc a Roma: si lancia dal tetto, i poliziotti lo afferrano per le caviglie