FDA 510(k)

FilmArray 血培养鉴定 (BCID) 面板，用于 FilmArray Torch

K号: K160457 · 2016-03-15

决定日期2016-03-15

产品代码PEN

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决定实质等同

器械摘要

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K160457. 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 FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K160457.

When did FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch receive FDA 510(k) clearance?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch received FDA 510(k) clearance on 2016-03-15, under 510(k) number K160457.

Who is the listed applicant for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

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

What is the FDA product code for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

The FDA product code for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is PEN.

列明Biofire Diagnostics, LLC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。

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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 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.

官方来源

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