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FDA Issues EUA for Innovita Biological

Industry news | 30 November, 2020 | CACLP

On November 25, 2020(Beijing time), the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Innovita Biological ' novel coronavirus Innovita  2019-nCoV Ab Test (Colloidal gold).

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The reagent has been approved by FDA after obtainingNational Medical Products Administration, EU market access and multi-country registration approval, which will enable Innovita Biological's rapid detection reagent for novel coronavirus to be used more in overseas countries to help fight the epidemic.

 

About Innovita :

Established in 2006 in Beijing, Innovita Biological Technology Co., Ltd. is a Chinese high-tech enterprise specialized in R&D, manufacturing, marketing and after-sales service of In-vitro diagnostic tests. 

In 2011 Innovita extended a new plant in Tangshan city of Hebei province-Innovita (Tangshan) Biological Technology Co., Ltd., which was designed as five new production lines: colloidal gold, real-time PCR, chemiluminescence, ELISA and biochips. The facility covers 250 acres (160,000 square meters) and is equipped with a purification plant of 4,000 square meters. The designed annual output can reach 20 million tests. Currently it has got ten invention patents. With certification of CE, ISO 13485 and GMP, Innovita has an extensive product line covering Fertility, Infectious Diseases, Sexually Transmitted Diseases, TORCH, Respiratory Diseases, Drug Abuse, Tumor Marker and Cardiac marker tests. 

Except for Innovita brand, it also provides OEM, ODM and technology support to customers. Innovita persists in the purpose of "Technology Creates Wonderful Life" and adheres to the business philosophy of "Quality first. & Serve Customers". It has been and will keep on aiming at providing high quality products and excellent after-sales services to both domestic and overseas customers.

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