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试剂盒制造商Copan Diagnostics尿液收集和运输设备获FDA批准 Copan Diagnostics’ urine collection and transport device gains FDA clearance Medical Device Network 等信源发布 2024-12-10 12:03 

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Copan Diagnostics has received the US Food and Drug Administration (FDA) clearance for its urine collection and transport system, UriSponge

Copan Diagnostics 的尿液收集和运输系统 UriSponge 已获得美国食品和药物管理局 (FDA) 的批准。

UriSponge is designed to address the high volume of urine samples processed annually, which accounts for nearly 70% of all specimens in clinical laboratories.

UriSponge 旨在处理每年处理的大量尿液样本，这些样本占临床实验室所有样本的近 70%。

It provides a user-friendly and cost-effective method for healthcare providers and clinical labs to collect, preserve and transport urine specimens.

它为医疗保健提供者和临床实验室提供了一种用户友好且经济有效的方法来收集、保存和运输尿液样本。

The device simplifies the transfer of urine from a sterile container to a tube with the help of a quick dip-and-close method that streamlines workflow and decreases procedural steps.

该装置利用快速浸入-关闭方法简化了尿液从无菌容器到管道的转移，从而简化了工作流程并减少了程序步骤。

The system’s screw-cap tube comes with a plastic applicator and sponges with preservatives. These preservatives activate upon contact with urine, maintaining the sample’s stability during transport, thereby ensuring ‘reliable’ outcomes and reducing contamination or degradation risks.

该系统的螺旋盖管配有塑料涂抹器和含有防腐剂的海绵。这些防腐剂在接触尿液后会激活，在运输过程中保持样本的稳定性，从而确保“可靠”的结果并降低污染或降解风险。

Its design eliminates the need for precise fill lines or additional mixing, simplifying the preservation process and reducing the necessity for extra consumables.

其设计无需精确的填充线或额外的混合，简化了保存过程并减少了对额外消耗品的需求。

The system’s advanced preservatives are key to maintaining specimen integrity, providing an alternative to traditional collection methods that often require strict handling protocols.

该系统的先进防腐剂是维持标本完整性的关键，为通常需要严格处理规程的传统收集方法提供了一种替代方法。

UriSponge is also designed to integrate with the company’s laboratory automation systems such as the WASP Walk-Away Specimen Processor, which automates key tasks related to microbiology specimen processing.

UriSponge 还可以与公司的实验室自动化系统（如 WASP Walk-Away Specimen Processor）集成，该系统可以自动执行与微生物学标本处理相关的关键任务。

This integration with Copan’s full laboratory automation solution offers a comprehensive approach to specimen management, from collection to analysis, enhancing laboratory productivity and consistency.

与 Copan 全实验室自动化解决方案的整合提供了从收集到分析的全面标本管理方法，提高了实验室的工作效率和一致性。

UriSponge will be available through US distribution partners starting early next year. This device is already available across the globe.

UriSponge 将于明年初通过美国分销合作伙伴发售。该设备目前已在全球发售。

Copan Diagnostics CEO Fabrizio Mazzochi said: “Copan is dedicated to advancing laboratory practices through groundbreaking innovation.

Copan Diagnostics 首席执行官 Fabrizio Mazzochi 表示：“Copan 致力于通过突破性创新推动实验室实践。

“UriSponge provides a reliable and efficient solution that supports laboratory needs while offering healthcare providers a safe, streamlined process.”

“UriSponge 提供了可靠、高效的解决方案，可支持实验室需求，同时为医疗保健提供者提供安全、简化的流程。”

In January this year, the company received the third FDA clearance for its pre-analytical processor, Colibrí. It features a fully automated specimen preparation platform for MALDI-TOF ID targets and bacterial suspensions for antibiotic susceptibility testing, comprising the Colibrí Vision System and Colibrí Preparation Station.

今年 1 月，该公司的预分析处理器 Colibrí 获得了 FDA 的第三次批准。它具有一个用于 MALDI-TOF ID 目标和用于抗生素敏感性测试的细菌悬浮液的全自动标本制备平台，包括 Colibrí 视觉系统和 Colibrí 制备站。

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