FDA 510(k)

xTAG 消化道病原體面板 (GPP)

K 號：K191161 · 2019-11-12

決定日期2019-11-12

產品代碼PCH

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

xTAG Gastrointestinal Pathogen Panel (GPP) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K191161. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the xTAG Gastrointestinal Pathogen Panel (GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP) is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K191161.

When did xTAG Gastrointestinal Pathogen Panel (GPP) receive FDA 510(k) clearance?

xTAG Gastrointestinal Pathogen Panel (GPP) received FDA 510(k) clearance on 2019-11-12, under 510(k) number K191161.

Who is the listed applicant for xTAG Gastrointestinal Pathogen Panel (GPP)?

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

What is the FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP)?

The FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP) is PCH.

其他以 Luminex Molecular Diagnostics, Inc. 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。

K242613NxTAG® 呼吸道病原體檢測組合 K231758NxTAG 呼吸道病原體面板 v2 (NxTAG RPP v2)K193167NxTAG 呼吸道病原體面板，NxTAG 呼吸道病原體面板檔案，SYNCT 軟體 K191160xTAG 消化道病原體檢測組合（GPP），xTAG 資料分析軟體（TDAS GPP）K183030xTAG 消化道病原體檢測組合（GPP），xTAG 資料分析軟體（TDAS GPP）K183023xTAG 消化道病原體檢測組合（GPP），xTAG 資料分析軟體（TDAS GPP）

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相關器械（代碼：PCH）

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Luminex Corporation K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251721Xpert GI PanelCepheid K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251993山貓融合內分泌系統廣範細菌試驗Hologic, Inc.K251868山貓融合胃腸細菌試驗Hologic

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