diagnostic-medical-device Downloads
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METAglut1™ is an in Vitro Diagnostic Medical Device used to aid in the diagnosis of the GLUT1 Deficiency Syndrome (GLUT1DS). It is a regulated health product that bears the CE mark. The first test for the daily practice developed from the METAdiag platform. ...
Optical Q CRP is an in vitro diagnostic medical device that quantify C-reactive protein (CRP) in human blood using immunofluorescence method. This helps to monitor the diagnosis or progress of inflammation in the body through the quantification of ...
AltoStar® Detection completes the final part of the AltoStar® Automation System AM 16 Workflow with two units of the real-time PCR Cycler CFX96™ Deep Well Dx System (Bio-Rad). All other relevant hardware, like a fully equipped PC and handheld barcode scanner, are included. The CFX96™ Deep Well Dx System is CE-IVD marked, in compliance with the European Union diagnostic ...
Optical Q HbA1c is an in vitro diagnostic medical device that quantify Glycated Hemoglobin (HbA1c) in human blood using immunofluorescence method. This helps to monitor the diagnosis diabetes and to facilitate the longterm monitoring of blood glucose level from ...
Optical Q beta-hCG is an in vitro diagnostic medical device that quantify Beta-Human Chorionic gonadotropin (beta-hCG) in human serum or plasma using immunofluorescence. This helps to diagnose or monitor for pregnancy, trophoblastic disease, or germ cell ...
TÜV Rheinland Product Safety GmbH as a “Notified Body” for all medical devices, including active implantable medical devices and in-vitro diagnostic medical devices, TÜV is the partner you are looking for.TÜV can offer certification for products and quality management systems for ...
Focused on the unique needs of device and diagnostics manufacturers, ICON has broad experience in supporting trials of respiratory disease and infectious disease affecting respiratory function. The prevalence of respiratory diseases will continue to rise as our global population ages and the incidence of chronic diseases, such as COPD and asthma, increases exponentially. ICON has considerable ...
ByICON plc
We developed our versatile Parasite Suspensions to help labs QC their parasitology diagnostic kits and methods, microscopic examinations, staining procedures, and proficiency programs. Designed to mimic a patient sample for simple control processing, these economical and easy-to-use Parasite Suspensions outperform similar products on the market. They are packaged in a vial containing a 1 ml ...
With the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) becoming applicable in May 2022, the European Bioanalysis Forum, as many others, is looking at the impact of this regulation on (bio)pharmaceutical drug research and development. Already, we observe a growing concern of the industry on potential scope creep of the IVDR into early clinical studies for assets where it is believed the ...