06/02/2026
Recently, Snibe obtained IVDR Class D CE certification for MAGLUMI assays targeting Anti-HBs, HBeAg, Anti-HBc IgM, and Anti-HBe, which enables Snibe to enhance its infectious disease panel to achieve full IVDR CE Class D with 9 key assays covering HIV, HBV, HCV, and Syphilis.
This full-panel validation underscores our commitment to delivering diagnostics trusted to meet the world's highest regulatory benchmarks, empowering laboratories with reliable, compliant testing solutions.
Full article: https://www.snibe.com/en/news/list/665.html