Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea

Reuters

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Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea

Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. The HD-X Simoa platform is recognized for its ultrasensitive biomarker detection, playing a crucial role in advancing Alzheimer's disease diagnostics and research. This approval further solidifies Quanterix's position in the neurodegenerative space, supporting both clinical trials and diagnostic testing.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20250623801054) on June 23, 2025, and is solely responsible for the information contained therein.

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Quanterix Corporati","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"QTRX":"Quanterix Corp","BK4121":"生命科学工具和服务"},"translate_title":"Quanterix Corporation的HD-X Simoa免疫分析仪在韩国获得1类医疗器械批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"QTRX":0.9},"content_text":"Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea\n    \n\n        Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. 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