FDA 510(k)

LIAISON PLEX 革兰氏阴性血培养检测

K号: K243013 · 2025-04-18

决定日期2025-04-18

产品代码PEN

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决定实质等同

器械摘要

LIAISON PLEX Gram-Negative Blood Culture Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K243013. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON PLEX Gram-Negative Blood Culture Assay?

LIAISON PLEX Gram-Negative Blood Culture Assay is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Luminex Corporation. The 510(k) number is K243013.

When did LIAISON PLEX Gram-Negative Blood Culture Assay receive FDA 510(k) clearance?

LIAISON PLEX Gram-Negative Blood Culture Assay received FDA 510(k) clearance on 2025-04-18, under 510(k) number K243013.

Who is the listed applicant for LIAISON PLEX Gram-Negative Blood Culture Assay?

The FDA 510(k) record lists Luminex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON PLEX Gram-Negative Blood Culture Assay?

The FDA product code for LIAISON PLEX Gram-Negative Blood Culture Assay is PEN.

列明Luminex Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253722LIAISON PLEX 胃肠道灵活检测 K243490LIAISON PLEX 革兰氏阳性血培养检测 K240627LIAISON PLEX 酵母血培养检测 K233410LIAISON PLEX 呼吸道灵活检测 K191742ARIES MRSA 测试 K172402ARIES Group A Strep 测试，ARIES Group A Strep 测试方案文件包

查看所有 13 个设备 →

相关器械（代码：PEN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262168QIAstat-Dx BCID GN Plus 抗生素耐药性检测板QIAGEN GmbH K243759BIOFIRE血培养鉴定2（BCID2）面板（RFIT-ASY-0147（30包装）RFIT-ASY-0148（6包装））Biofire Diagnostics, LLC K213236ePlex 血培养鉴定革兰氏阴性（BCID-GN）试剂盒Genmark Diagnostics, Incorporated K193519BioFire 血培养鉴定 2 (BCID2) 面板Biofire Diagnostics, LLC K190341iC-GN iC-卡式盒，适用于iC-系统Icubate, Inc.K182619ePlex 血培养鉴定革兰氏阴性（BCID-GN）试剂盒Genmark Diagnostics, Incorporated

官方来源

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