Home / Business and Economy / Cupid Earns EU IVDR Nod for Key Health Tests
Cupid Earns EU IVDR Nod for Key Health Tests
28 Jan
Summary
- Cupid secured CE IVDR certification for two vital diagnostic kits.
- The kits are for HIV 1&2 antibody detection and Hepatitis B surface antigen.
- This approval allows marketing across the European Economic Area.
Cupid Limited has achieved a significant regulatory milestone by receiving CE (EU IVDR) Certification for two of its in-vitro diagnostic (IVD) products. The certified kits include the CupiKIT HIV 1&2 Antibody Test Kit and the CupiKIT Hepatitis B Surface Antigen (HBsAg) Test Kit.
These certifications were awarded under the rigorous European Union In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), recognized as one of the world's most stringent regulatory standards. This successful validation empowers Cupid Limited to now market and distribute these certified diagnostic solutions across the entire European Economic Area (EEA).
Furthermore, the CE mark facilitates market entry into other international territories that acknowledge this certification. The achievement underscores Cupid's commitment to quality and regulatory compliance in providing essential diagnostic tools.
