免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

BIOFIRE FILMARRAY 消化道（GI）面板中

K 號：K243885 · 2025-01-16

申請人Biofire Diagnostics, LLC
決定日期2025-01-16
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

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid 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 2025-01-16 under 510(k) number K243885. 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 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K243885.

When did BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid receive FDA 510(k) clearance?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid received FDA 510(k) clearance on 2025-01-16, under 510(k) number K243885.

Who is the listed applicant for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid?

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 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid?

The FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is PCH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K230719BIOFIRE® SPOTFIRE® 呼吸 (R) 面板迷你版

查看所有 20 項裝置 →

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 CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑