FDA 510(k)

ePlex 血液培養識別面板 - 革蘭氏陽性 (BCID-GP 面板)

K 號：K181663 · 2018-12-20

決定日期2018-12-20

產品代碼PAM

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

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) 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 2018-12-20 under 510(k) number K181663. The device is classified under product code PAM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel?

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K181663.

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

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel received FDA 510(k) clearance on 2018-12-20, under 510(k) number K181663.

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

The FDA product code for ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel is PAM.

其他以 Genmark Diagnostics, Incorporated 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。

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相關器械（代碼：PAM）

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。

K254194QIAstat-Dx BCID GPF Plus 抗藥性細菌檢測面板QIAGEN GmbH K243490LIAISON PLEX 革蘭氏陽性血液培養試劑Luminex Corporation K163390iC-GPC Assay™ 適用於iC-System™Icubate, Inc.K152470大盆地葡萄球菌ID/R血液培養組合Great Basin Scientific, Inc.

官方來源

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