Maccura expands diagnostic portfolio with new product registrations

Maccura Biotechnology has obtained medical device registration certificates for three new in-vitro diagnostic products from the Sichuan Provincial Medical Products Administration. These include a quality control product for blood cell analyzers (Registration No. 20252400168), a glial fibrillary acidic protein quantitative assay kit (direct chemiluminescence method) (Registration No. 20252400179), and a calibrator for blood cell analyzers (Registration No. 20252400180). All three registrations are valid until October 2030.

The glial fibrillary acidic protein assay kit, a new chemiluminescence product, is intended for auxiliary diagnosis of central nervous system diseases. It is compatible with Maccura's i6000, i3000, i1000, and i800 series automated chemiluminescence immunoassay analyzers. This addition brings the company's total registered reagent products on its chemiluminescence platform to 138.

The blood cell analyzer quality control and calibrator products are new additions to Maccura's hematology platform. They are designed to monitor instrument performance and ensure accuracy and traceability of blood cell analysis results across WBC, RBC, HGB, HCT, and PLT parameters. Maccura anticipates these new registrations will enrich its product portfolio and strengthen its market competitiveness.