GeneMatrix, 7 products of in vitro diagnostic medical devices approved by the Food and Drug Administration (KFDA) > notice

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GeneMatrix, 7 products of in vitro diagnostic medical devices approved by the Food and Drug Administration (KFDA)

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작성일 13-01-07 13:29


GeneMatrix has obtained 7 kinds of diagnostic products using its original molecular diagnostic technology as products for in vitro diagnostic analyzers from the Food and Drug Administration (hereinafter referred to as the Korea Food and Drug Administration), and its subsidiary, HBI, is also licensed for 5 types of products. Received.

The items that have been approved this time are core products based on original technology that accurately and sensitively diagnoses the causative gene through mass analysis. Hepatitis B diagnosis products, hepatitis C diagnosis products, cervical cancer diagnosis products, liver cancer diagnosis products, congenital hearing loss. There are 7 types including diagnostic products. These products are capable of early diagnosis of diseases, prognosis determination and treatment selection, treatment response monitoring, etc., and have been recognized for their excellence, safety and effectiveness by passing deliberation on new medical technology evaluation and receiving national health insurance benefits.

In particular, Papillotyper, a cervical cancer diagnosis product, was developed as a part of the new technology convergence growth engine project, an industry-academic cooperation program of the Ministry of Education, Science and Technology, and is evaluated as having the world's highest level of detection of viruses that cause cervical cancer. Myocardial infarction diagnostic medical devices, syphilis diagnostic medical devices, and blood clot diagnostic medical devices, etc., which are acquired by subsidiary HBI, can achieve objective and reproducible results, and are U-healthcare products suitable for an aging society.

We will do our best to ensure that the domestic in vitro diagnostic product licensing system is settled quickly and provide quality medical services to the public, and we plan to actively target the domestic and overseas in vitro diagnostic market with this registration with the KFDA.

Data inquiry: 031-628-2000