Shenzhen new industries obtains medical device registration
Shenzhen New Industries Biomedical Engineering Co., Ltd. announced it has received medical device registration certificates from the Guangdong Provincial Drug Administration for three products. The approved products include the Androstenedione Assay Kit (chemiluminescence method), Total Immunoglobulin E Assay Kit (chemiluminescence immunoassay), and Glycocholic Acid Assay Kit (latex immunoturbidimetry). These kits expand the company's diagnostic offerings in sex hormones, immunoglobulins, and liver function testing. The company holds 193 medical device registration certificates for chemiluminescence reagents (277 registered certificates) and 68 for biochemical reagents (100 registered certificates). The company anticipates a positive impact on its overall development but does not expect a significant impact on the company's immediate production, operations, or financial performance.
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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