Core Insights - Oriental Bio (688298.SH) announced that its subsidiary, Shanghai Wanzijian Biotechnology Co., Ltd., along with American Hengjian, has recently obtained medical device product registration certificates in China, Australia, and Singapore [1] Domestic Medical Device Registration - Product Name: Gastrin 17 Test Kit (Flow Cytometry Method); Certificate Number: Hu Xie Zhu Zhun 20252400429; Intended Use: For in vitro quantitative detection of Gastrin 17 (G-17) levels in human serum, primarily for assisting in the diagnosis of atrophic gastritis [1] - Product Name: N-terminal Pro B-type Natriuretic Peptide Test Kit (Magnetic Particle Chemiluminescence Method); Certificate Number: Hu Xie Zhu Zhun 20252400426; Intended Use: For in vitro quantitative detection of N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in human serum and plasma samples, primarily for assisting in the diagnosis of heart failure [1] International Medical Device Registration - Product Name: Healgen Rapid Test for COVID-19/Influenza A/B Antigen (Self-test); Certificate Number: DV-2024-MC24333-1; Intended Use: A lateral flow immunochromatographic test for qualitative detection and differentiation of Influenza A virus, Influenza B virus nucleoprotein antigens, and SARS-CoV-2 nucleocapsid antigens. This test is suitable for individuals aged 14 and above, requiring self-collected anterior nasal swab samples for testing. Specific testing conditions: SARS-CoV-2 infection must be tested within 7 days of symptom onset, while Influenza A and B infections must be tested within 4 days of symptom onset [1][2]

Core Insights - Oriental Bio (688298.SH) announced that its subsidiary, Shanghai Wanzijian Biotechnology Co., Ltd., along with American Hengjian, has recently obtained medical device product registration certificates in China, Australia, and Singapore [1] Domestic Medical Device Registration - Product Name: Gastrin 17 Test Kit (Flow Cytometry Method); Certificate Number: Hu Xie Zhu Zheng 20252400429; Intended Use: For in vitro quantitative detection of gastrin 17 (G-17) levels in human serum, primarily used for the auxiliary diagnosis of atrophic gastritis [1] - Product Name: N-terminal Pro B-type Natriuretic Peptide Test Kit (Magnetic Particle Chemiluminescence Method); Certificate Number: Hu Xie Zhu Zheng 20252400426; Intended Use: For in vitro quantitative detection of N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in human serum and plasma samples, primarily used for the auxiliary diagnosis of heart failure [1] International Medical Device Registration - Product Name: Healgen Rapid Test for COVID-19/Influenza A/B Antigen (Self-test); Certificate Number: DV-2024-MC24333-1; Intended Use: A lateral flow immunochromatographic test for qualitative detection and differentiation of Influenza A virus, Influenza B virus nucleoprotein antigens, and SARS-CoV-2 nucleocapsid antigens. This test is suitable for individuals aged 14 and above and requires self-collected anterior nasal swab samples for testing. Specific testing conditions: SARS-CoV-2 infection must be tested within 7 days of symptom onset, and Influenza A and B infections must be tested within 4 days of symptom onset [1][2]