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Original Article | 2024-04-01
Experience of Approval of In Vitro Diagnostic Medical Devices in Korea and Europe and Clinical Performance Study

Hwan Tae Lee, M.D.¹, Jeong-Yeal Ahn, M.D.¹, Ja Young Seo, M.D.¹, Yiel-Hea Seo, M.D.¹, Pil-Whan Park, M.D.¹, Kyung-Hee Kim, M.D.², Jaehyung You³, Wookwan Park³, Woo Jin Kim, M.D.⁴, Young Ho Yoon, M.D.⁴, Gwiyoung Oh, M.D.⁴, Daewon Kim, M.D. ¹

https://doi.org/10.47429/lmo.2024.14.2.118
Lab Med Online 2024; 14(2): 118-126
Keywords:
In vitro diagnostic medical device, Ministry of Food and Drug Safety, In Vitro Diagnostic Medical Device Regulation, Diagnostic test approval, Mycobacterium tuberculosis, Sexually transmitted infection

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Original Article | 2023-04-01
Current Status and Perspectives for in vitro Medical Devices for Infectious Disease Diagnosis - Survey of Product Development and Clinical Trials

Soomin Kim, M.S.¹, Seungjun Lee, M.D.^1,2, Sunjoo Kim, M.D. ^1,2,3

https://doi.org/10.47429/lmo.2023.13.2.65
Lab Med Online 2023; 13(2): 65-71
Keywords:
Infectious diseases, In vitro diagnostic medical device, Medical device legislation, Reagent kits

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