FDA 510(k)

LIAISON PLEX 革蘭氏陰細菌血液培養試劑

K 號：K243013 · 2025-04-18

決定日期2025-04-18

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

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.

常見問題

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.

其他以 Luminex Corporation 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。

K253722LIAISON PLEX 消化道柔軟性試驗 K243490LIAISON PLEX 革蘭氏陽性血液培養試劑 K240627LIAISON PLEX 酵母血培養試劑 K233410LIAISON PLEX 呼吸道 Flex 檢驗試劑 K191742ARIES MRSA 試劑 K172402ARIES A 群鏈球菌試劑，ARIES A 群鏈球菌試劑實驗方案文件套件

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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 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.K182619ePlex 血液培養識別革蘭氏陰性（BCID-GN）面板Genmark Diagnostics, Incorporated

官方來源

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