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新产业(300832.SZ):全自动化学发光免疫分析仪MAGLUMI X3获得美国FDA 510(k)准入

New industry (300832.SZ): MAGLUMI X3, a fully automatic chemiluminescence immunoanalyzer, obtained US FDA 510 (k) approval

Zhitong Finance ·  Apr 14 04:48

New Industries (300832.SZ) issued an announcement. Recently, the company received the US Food and Drug Administration (English...

Zhitong Finance App News, New Industry (300832.SZ) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”). The company's fully automatic chemiluminescence immunoassay analyzer MAGLUMI X3 and 25-hydroxyvitamin D test kit (chemiluminescence immunoassay) products obtained US FDA 510 (k) approval.

The above products have been approved by the US FDA 510 (k), indicating that the company's fully automatic chemiluminescence immunoassay analyzer MAGLUMIX3 and 25-hydroxyvitamin D test kit (chemiluminescence immunoassay) is eligible to enter the US market, which is conducive to further enhancing the overall competitiveness of the company's products in overseas markets, and will have a positive impact on the company's future operations.

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