Securities code: 300463 securities abbreviation: Maccura Biotechnology Co.Ltd(300463) Announcement No.: 2022-008
Maccura Biotechnology Co.Ltd(300463)
Announcement on obtaining product registration certificate for new products of the company
The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete without false records, misleading statements or major omissions.
Maccura Biotechnology Co.Ltd(300463) (hereinafter referred to as "the company") recently received the medical device registration certificate issued by Sichuan provincial drug administration. The details are as follows: I. details of the product registration certificate
Serial product name registration certificate number registration certificate validity intended use
Number category
Cardiac troponin I was measured by Chuanji injection standard from January 21, 2022 to the concentration of 20222400014 I in human serum and blood determination kit (fluorescence immunoassay Ⅱ plasma or whole blood sample central troponin chromatography on January 20, 2027).
The myoglobin determination reagent chuanxizhu Zhun was used for quantitative determination of human serum and blood in vitro from January 21, 2022 to 2 boxes (fluorescence immunochromatography Ⅱ concentration method of myoglobin in plasma or whole blood samples on January 20, 2027) 20222400015 degrees.
Creatine kinase isozyme was measured by Chuanji injection standard from January 21, 2022 to 20222400016 enzyme concentration in human serum and blood determination kit (fluorescence immunoassay Ⅱ plasma or whole blood samples on January 20, 2027).
2、 Impact on the company
Cardiac troponin I Assay Kit (fluorescence immunochromatography), myoglobin assay kit (fluorescence immunochromatography) and creatine kinase isoenzyme assay kit (fluorescence immunochromatography) are new products of the company's rapid detection (POCT) product platform, which are mainly used to assist in the diagnosis of acute myocardial infarction and the evaluation of thrombolytic efficacy of patients, Obtaining the registration certificate for the above three products will help to improve the company's comprehensive market competitiveness and will have a positive impact on the market expansion and the company's future operation. 3、 Risk tips
Securities code: 300463 securities abbreviation: Maccura Biotechnology Co.Ltd(300463) Announcement No.: 2022-008
The actual sales of the products involved in the above registration certificate depends on the future marketing effect. At present, it is impossible to predict the impact of the product on the company's future operating revenue. Please pay attention to the investment risk.
It is hereby announced.
Maccura Biotechnology Co.Ltd(300463) board of directors January 28, 2002