Mercodia Will Market Their Oxidized LDL ELISA as an In-vitro Diagnostic for Clinical Use
The United States Food and Drug Administration (FDA) has determined that the Mercodia Oxidized LDL ELISA can be used clinically as an IVD. Oxidized LDL has been shown to play a key role in the initiation and progression of atherosclerosis, making the Mercodia Oxidized LDL ELISA a critical biomarker in cardiovascular disease-related studies and the most widely used method commercially available today.
Winston Salem, NC, September 27, 2010 --(PR.com)-- The United States Food and Drug Administration (FDA) has determined that the Mercodia Oxidized LDL ELISA can be used clinically as an IVD.
FDA Classification: Clinical Chemistry Test Systems - Sec. 862.1475 - Lipoprotein test system - “Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.”1.
Oxidized LDL has been shown to play a key role in the initiation and progression of atherosclerosis, making the Mercodia Oxidized LDL ELISA a critical biomarker in cardiovascular disease-related studies and the most widely used method commercially available today.
Carissa Jones, Operations Director for Mercodia Inc, sees the clinical use of the Mercodia Oxidized LDL ELISA as a first step toward the incorporation of oxidized LDL as a standard and accepted lipoprotein measurement: - “For the last ten years, over 350 publications have supported oxidized LDL as a marker of atherosclerosis, cardiovascular disease and Metabolic Syndrome. Now it is time for us to make this information available to the clinicians, the value of adding oxidized LDL measurement in the diagnosis and treatment of lipid disorders.”
The Mercodia Oxidized LDL ELISA is reimbursable by Medicare in most states.
Mercodia AB is a Swedish biotech company focusing on the development of immunoassays within the field of metabolic disorders. Mercodia is a world-leading supplier to all major international markets, providing a professional scientific support system to develop novel applications for existing products and unique diagnostics for emerging markets.
Mercodia has demonstrated compliance with “International Organization for Standardization (ISO) in 13485:2003, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.” The Mercodia Quality System has also implemented practices and procedures that promote compliance with Quality System Regulation (QSR) including current Good Manufacturing Practices (GMP), as set forth by the FDA.
For more information on the Mercodia Oxidized LDL ELISA, please visit our website at www.mercodia.com.
Contact Mercodia Inc
Carissa Jones | carissa.jones@mercodia.com
Phone +1 336 725 8623
Mobile +1 336 655 9096
###
FDA Classification: Clinical Chemistry Test Systems - Sec. 862.1475 - Lipoprotein test system - “Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.”1.
Oxidized LDL has been shown to play a key role in the initiation and progression of atherosclerosis, making the Mercodia Oxidized LDL ELISA a critical biomarker in cardiovascular disease-related studies and the most widely used method commercially available today.
Carissa Jones, Operations Director for Mercodia Inc, sees the clinical use of the Mercodia Oxidized LDL ELISA as a first step toward the incorporation of oxidized LDL as a standard and accepted lipoprotein measurement: - “For the last ten years, over 350 publications have supported oxidized LDL as a marker of atherosclerosis, cardiovascular disease and Metabolic Syndrome. Now it is time for us to make this information available to the clinicians, the value of adding oxidized LDL measurement in the diagnosis and treatment of lipid disorders.”
The Mercodia Oxidized LDL ELISA is reimbursable by Medicare in most states.
Mercodia AB is a Swedish biotech company focusing on the development of immunoassays within the field of metabolic disorders. Mercodia is a world-leading supplier to all major international markets, providing a professional scientific support system to develop novel applications for existing products and unique diagnostics for emerging markets.
Mercodia has demonstrated compliance with “International Organization for Standardization (ISO) in 13485:2003, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.” The Mercodia Quality System has also implemented practices and procedures that promote compliance with Quality System Regulation (QSR) including current Good Manufacturing Practices (GMP), as set forth by the FDA.
For more information on the Mercodia Oxidized LDL ELISA, please visit our website at www.mercodia.com.
Contact Mercodia Inc
Carissa Jones | carissa.jones@mercodia.com
Phone +1 336 725 8623
Mobile +1 336 655 9096
###
Contact
Mercodia Inc.
Carissa Jones
336-725-8623
www.mercodia.com
Carissa Jones
336-725-8623
www.mercodia.com
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