Maccura receives registration certificates for new diagnostic products

Maccura Biotechnology (SZSE:300463) announced that it has received medical device registration certificates from the National Medical Products Administration for two new in-vitro diagnostic reagent products. The products include the irregular antibody detection red blood cell kit (column agglutination method), intended for detecting irregular antibodies in human plasma, and the Mycoplasma pneumoniae IgM antibody detection kit (direct chemiluminescence method), used for the auxiliary diagnosis of Mycoplasma pneumoniae infections. Both certificates are valid from June 20, 2025, to June 19, 2030. The Mycoplasma pneumoniae IgM antibody detection kit will be used with the company’s i6000, i3000, i1000, and i800 series of automated chemiluminescence immunoassay analyzers. Maccura now holds 133 reagent registration certificates for its direct chemiluminescence platform. The company anticipates these new product registrations will enhance its market competitiveness, positively impacting future operations and market expansion. However, the company also cautioned that actual sales are subject to future market promotion efforts, and investors should be aware of investment risks.