(주)비욘드디엑스 체외진단 의료기기 제조업 허가 및 ForeCheck LC 수출용 허가 획득
2024-03-25 15:55:11
㈜비욘드디엑스는 식품의약품안전처로부터 폐암 조기 진단을 위한 체외진단의료기기(3등급)의 수출용 제조 허가를 받았습니다.
승인 내용은 체외진단의료기기 품목별 제조 허가로 제품명은 Forecheck LC, 1종입니다. ㈜비욘드디엑스의 해당 제품은 당사가 보유한 핵심 기반 기술인 “다중통합분석솔루션”이 적용되어 내부 탐색 임상에서 민감도 81.9% 특이도 90.1%로 표준 진단 대비 우수한 성능을 구현하고 있습니다.
또한, 경쟁 제품 대비 높은 가격 경쟁력과 분석 소요 기간 단축이 되었다는 것에 장점이 있습니다.
금번 수출 허가를 통해 해당 제품에 대한 니즈가 큰 중국을 필두로 유럽
미국 등의 진출을 구체화할 계획이며, 더불어,국내 허가
및 출시를 위해 24년 하반기 해당 제품의 확증 입상을 준비 중에 있습니다.
Privacy Policy
BeyondDx collects the following personal information for services consultation, inquiries, and job applications:
BeyondDx utilizes the collected personal information for the following purposes:
In principle, personal information is disposed of without delay after the purpose of collection or provision has been achieved. During the period of using services, research, and job application procedures, personal information is retained by BeyondDx.
However, it is generally disposed of without delay when the purpose of collecting or providing personal information is achieved. In cases where issues arise during the process of discussing services and job applications, information necessary for compulsory blocking and measures against malicious users will be retained.
BeyondDx disposes of personal information without delay after the purpose of collecting and using it has been achieved.
The procedure and method of disposal are as follows:
BeyondDx generally does not provide users' personal information to external entities. However, exceptions apply in the following cases:
BeyondDx does not entrust personal information to external companies without the user's consent. If necessary, the target and content of the entrusted work will be notified to the user, and the process will proceed after obtaining prior consent.
Users and legal representatives can access, modify, or request deletion of personal information of themselves or children under 14 years of age at any time.
For inquiries related to the viewing of personal information of users or children under 14 years of age, contact the personal information protection manager through writing, telephone, or email for prompt action. If a user requests correction of incorrect personal information, the information will not be used or provided until the correction is completed. If incorrect personal information has already been provided to a third party, the results of the correction will be promptly notified to the third party for correction.
BeyondDx processes terminated or deleted personal information according to the retention and usage period of collected personal information.
BeyondDx operates information storage and retrieval devices such as "cookies" to collect user information.
Cookies are small text files sent by servers used to operate BeyondDx's website to the user's browser. These files are stored on the user's computer hard drive. BeyondDx uses cookies for the following purposes:
BeyondDx protects user personal information and handles complaints related to personal information. Below are the related departments and personal information protection manager designated by BeyondDx:
Personal Information Protection Manager
Name: Yoonjung Lee
Phone Number: 02-6337-0802 (Weekdays: 8:00 AM to 5:00 PM)
Email: yjlee@beyonddx.kr
For reporting or counseling on personal information infringement, contact the following organizations:
Personal Information Infringement Report Center (Phone 118, http://privacy.kisa.or.kr)
Personal Information Dispute Resolution Commission (Phone 1833-6972, http://www.kopico.go.kr)
Cyber Investigation Department of the Prosecutor's Office (Phone 1301, http://spo.go.kr/)
Cyber Safety Bureau of the National Police Agency (Phone 182, http://cyberbureau.police.go.kr/)