FDA 510(k)

FilmArray 血液培養識別（BCID）面板

K 號：K181493 · 2018-07-05

決定日期2018-07-05

產品代碼PEN

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

FilmArray Blood Culture Identification (BCID) Panel 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 2018-07-05 under 510(k) number K181493. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FilmArray Blood Culture Identification (BCID) Panel?

FilmArray Blood Culture Identification (BCID) Panel is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K181493.

When did FilmArray Blood Culture Identification (BCID) Panel receive FDA 510(k) clearance?

FilmArray Blood Culture Identification (BCID) Panel received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181493.

Who is the listed applicant for FilmArray Blood Culture Identification (BCID) Panel?

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?

The FDA product code for FilmArray Blood Culture Identification (BCID) Panel is PEN.

其他以 Biofire Diagnostics, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243544BIOFIRE SPOTFIRE 呼吸道/喉痛面板迷你版 K243885BIOFIRE FILMARRAY 消化道（GI）面板中 K243759BIOFIRE 血培養識別 2 (BCID2) 面板 (RFIT-ASY-0147 (30 套) RFIT-ASY-0148 (6 套))K242367BIOFIRE FILMARRAY 消化道（GI）面板 K241194BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板迷你版 K232954BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板

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相關器械（代碼：PEN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262168QIAstat-Dx BCID GN Plus 抗藥性面板QIAGEN GmbH K243013LIAISON PLEX 革蘭氏陰細菌血液培養試劑Luminex Corporation K243759BIOFIRE 血培養識別 2 (BCID2) 面板 (RFIT-ASY-0147 (30 套) RFIT-ASY-0148 (6 套))Biofire Diagnostics, LLC K213236ePlex 血液培養識別革蘭氏陰性（BCID-GN）面板Genmark Diagnostics, Incorporated K193519生物火血液培養識別2（BCID2）面板Biofire Diagnostics, LLC K190341iC-GN iC-卡匣，適用於iC-系統Icubate, Inc.

官方來源

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