FDA 510(k)

ePlex 血培养鉴定革兰氏阴性（BCID-GN）试剂盒

K号: K213236 · 2022-04-27

决定日期2022-04-27

产品代码PEN

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决定实质等同

器械摘要

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K213236. 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 ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K213236.

When did ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel receive FDA 510(k) clearance?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel received FDA 510(k) clearance on 2022-04-27, under 510(k) number K213236.

Who is the listed applicant for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

The FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is PEN.

列明Genmark Diagnostics, Incorporated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。

K182619ePlex 血培养鉴定革兰氏阴性（BCID-GN）试剂盒 K182690ePlex 血培养鉴定板真菌病原体（BCID-FP）板 K181663ePlex 血培养鉴定板 - 革兰氏阳性（BCID-GP）板 K163636ePlex 呼吸道病原体检测板 K163652ePlex 仪器 K152612eSensor 华法林敏感性唾液检测

查看所有 7 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 K243013LIAISON PLEX 革兰氏阴性血培养检测Luminex Corporation 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 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

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