Maccura expands IVD portfolio with new product registrations

Maccura Biotechnology Co., Ltd. announced the receipt of several medical device registration certificates (in-vitro diagnostic reagents) from China's National Medical Products Administration and Sichuan Provincial Medical Products Administration.

The new registrations include two coagulation quality control products, "Coagulation Composite Quality Control Plasma" and "Coagulation Composite Calibrator." These products are for quality control and calibration of various coagulation-related tests on Maccura's platform.

Additionally, the company obtained registration for "Coagulation Factor XI Activity Assay Kit (Coagulation Method)" and "Coagulation Factor XII Activity Assay Kit (Coagulation Method)." These new reagents will be used for the quantitative detection of coagulation factor XI and XII activity in human plasma, respectively, addressing deficiencies or reduced activity. Another significant addition is the "Neurofilament Light Chain Protein Assay Kit (Direct Chemiluminescence Method)," designed for quantitative determination of neurofilament light chain protein in human serum or plasma, aiding in the auxiliary diagnosis of traumatic brain injury.

These new products will be compatible with Maccura's existing automated coagulation analysis systems (H3800 and H5000 series) and automated chemiluminescence immunoassay analyzers (i6000, i3000, i1000, and i800 series). With these additions, Maccura has now accumulated 139 registered reagent products on its direct chemiluminescence platform, expanding its diagnostic menu to include thyroid function, infectious diseases, myocardial markers, tumor markers, and more.