9 MAGLUMI Infectious Diseases Assays Receive Top-Level Class D IVDR CE Certificate - Snibe Diagnostic丨CLIA products and Test Menu up to 260 parameters

Following its recent acquisition of IVDR Class D CE certification for MAGLUMI assays targeting Anti-HBs, HBeAg, Anti-HBc IgM, and Anti-HBe, Snibe has enhanced its infectious disease testing menu to achieve full IVDR CE Class D for a comprehensive panel of 9 key assays covering HIV, HBV, HCV, and Syphilis.

IVDR CE Class D represents the highest-risk category under the EU's stringent In Vitro Diagnostic Regulation, signifying the most rigorous assessment of clinical performance, safety, and quality. This certification is the top standard for diagnostics.

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.

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