Snibe Diagnostic secures new certificate for hepatitis A virus test kit
Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe Diagnostic) announced the acquisition of a new medical device registration certificate for its "Hepatitis A Virus Antibody Detection Reagent Kit (Magnetic Particle Chemiluminescence Immunoassay)." Issued by the National Medical Products Administration, this Class III medical device is valid from September 17, 2025, to September 16, 2030. The kit is designed for the qualitative detection of total Hepatitis A Virus (Anti-HAV) antibodies in human serum or plasma.
This new registration enhances Snibe Diagnostic's chemiluminescence immunoassay product line within the "infectious diseases" category. The company currently holds 197 chemiluminescence reagent product registrations, totaling 282 medical device registration certificates. The addition of this new product is expected to have a positive impact on the company's development.
While the new certificate is a positive development, Snibe Diagnostic stated that it does not anticipate a material impact on its short-term production, operations, or financial performance. Investors are advised to pay attention and be aware of potential investment risks.
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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