Maccura Biotechnology secures registration for new blood type control product

Maccura Biotechnology Co., Ltd. recently obtained a Medical Device Registration Certificate (In Vitro Diagnostic Reagent) from the National Medical Products Administration for its "Blood Type Identification and Irregular Antibody Screening Quality Control Product." The registration certificate, numbered 20253402373 (Category III), is valid from November 25, 2025, to November 24, 2030.

This new quality control product monitors laboratory testing system stability and enhances detection quality. It provides quality control for ABO positive and reverse typing, RhD typing, Rh blood type identification, and irregular antibody screening. It is compatible with Maccura's existing detection cards and reagent kits for manual and automated blood type analysis systems, approved for clinical detection but not for blood source screening.

The company anticipates this new product will enrich its product menu, strengthen market competitiveness, and positively impact future market expansion and business operations. However, Maccura issued a risk warning, stating actual sales depend on future market promotion, and its impact on future operating revenue is currently unpredictable. Investors are advised to be aware of investment risks.