NZY Mag Viral RNA/DNA Isolation Kit Earns CE-IVD Mark Under New EU IVDR Framework
The NZY Mag Viral RNA/DNA Isolation Kit, IVD has affixed CE-IVD marking under the new EU in vitro Diagnostic Regulation (IVDR) framework. This milestone reaffirms NZYtech's commitment to delivering cutting-edge solutions for nucleic acid purification.
The EU in vitro Diagnostic Regulation (IVDR) represents a significant change in European regulations for these type of devices. It is the start of a new era, imposing stricter requirements for safety, performance and traceability. This stringent framework is designed to guarantee that only high-quality, secure, and dependable in vitro diagnostic devices are made available in the market.
"Although compliance with IVDR is an important step for NZYTech, our vision is to keep in mind that this achievement is mainly for guaranteeing patient safety.", says Sandra Balseiro, NZYtech's Quality Director.
CE-IVD marking for the NZY Mag Viral RNA/DNA Isolation Kit demonstrates NZYtech's dedication to these new regulatory requirements. This qualification indicates that the product continues to meet rigorous EU standards for in vitro diagnostic devices, providing confidence in its performance and accuracy.
The NZY Mag Viral RNA/DNA Isolation Kit utilizes magnetic bead technology, designed for the recovery of RNA and DNA from viral particles found in transport medium from human nasopharyngeal swabs. Its efficiency, precision and user-friendliness make it an essential resource for diagnosing and researching viral infections.
- Magnetic Bead Technology: Harnesses magnetic beads to selectively extract viral RNA and DNA, ensuring high yields and purity.
- Versatility: Suitable for various sample types, including nasopharyngeal swabs, making it adaptable for diverse viral detection applications.
- Compatibility: Protocol options for NZY Mag Viral RNA/DNA Isolation Kit, IVD, support automated workflows in a variety of common platforms.
- Flexible protocol: Accommodates sample volume inputs of 200 μL of transport medium with an elution volume of 50 μL.
- CE-IVD Marking: Now CE-IVD marked under the new EU IVDR framework, guaranteeing compliance with European regulations for in vitro diagnostic devices.
CE-IVD marking under IVDR for the NZY Mag Viral RNA/DNA Isolation Kit is a significant achievement.
"At NZYtech, we are dedicated to addressing the evolving challenges posed by the EU In Vitro Diagnostic Regulation (IVDR). We are committed to pioneering innovation, adhering to stringent regulatory standards, and advancing patient care through cutting-edge solutions.", says Joana Brás, IVD Director for NZYtech.
This innovative kit, based on magnetic bead technology for efficient viral RNA and DNA recovery, continues to align with stringent EU IVDR requirements. Despite this new update, the kit’s catalogue number remains unchanged.