CE-IVD Certified Products
About CE-IVD
On May 26, 2022, In Vitro Diagnostic Regulation (IVDR 2017/746) became legally binding and requires that products used by laboratories doing genetic testing be either annually certified by the laboratory or be a certified IVDR product (CE-IVD marked). As an ISO 13485:2016 certified manufacturer of nucleic acid purification kits, Omega Bio-tek meets the requirements required to deliver CE-IVD marked products.
Receiving IVDR certification is proof of compliance with current regulations and the standards that go with them. As the manufacturer of a CE-IVD marked product, Omega Bio-tek has validated and continues to validate our product for its intended use and takes actions to improve the product to ensure that they are safe and effective.
CE-IVD Marked Products
The following products have been marked CE-IVD:
- Mag-Bind® Blood & Tissue DNA Kit CE IVD
- Mag-Bind® cfDNA Kit CE IVD
- Mag-Bind® Blood DNA HV Kit CE IVD
- Mag-Bind® Viral DNA/RNA Xpress Kit CE IVD
- MB Fit24™ Blood & Tissue DNA Kit CE IVD
- MB Fit24™ cfDNA Kit CE IVD
- MagBinder® Fit24 Nucleic Acid Purification System
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