Maccura expands diagnostic portfolio with new assay approvals
Maccura Biotechnology Co., Ltd. recently announced the approval of several new in-vitro diagnostic reagents. The National Medical Products Administration issued a registration certificate for the company's "Chlamydia pneumoniae IgG Antibody Detection Kit (Direct Chemiluminescence Method)." This new assay targets the qualitative detection of Chlamydia pneumoniae IgG antibodies in human serum or plasma.
Additionally, Maccura received multiple product registration certificates from both the National Medical Products Administration and the Sichuan Provincial Medical Products Administration. These include "Coagulation Composite Quality Control Plasma" and "Coagulation Composite Calibrator," which are new calibration and quality control products for coagulation-related tests. The "Neurofilament Light Chain Protein Detection Kit (Direct Chemiluminescence Method)" was also approved, aimed at diagnosing traumatic brain injury.
Further expanding its coagulation platform, the company secured approvals for the "Coagulation Factor XI Activity Detection Kit (Coagulation Method)" and "Coagulation Factor XII Activity Detection Kit (Coagulation Method)." These additions enhance Maccura’s product menu, supporting market competitiveness and future business growth. The company cautions investors that sales performance will depend on market promotion.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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