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FDA 510(k)

BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板

K 號：K232954 · 2024-03-26

申請人Biofire Diagnostics, LLC
決定日期2024-03-26
產品代碼QOF
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 SPOTFIRE Respiratory/Sore Throat (R/ST) 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 2024-03-26 under 510(k) number K232954. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel?

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K232954.

When did BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel receive FDA 510(k) clearance?

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel received FDA 510(k) clearance on 2024-03-26, under 510(k) number K232954.

Who is the listed applicant for BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) 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 BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel?

The FDA product code for BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is QOF.

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。

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

查看所有 20 項裝置 →

相關器械（代碼：QOF）

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。

K261336Xpert 呼吸檢測組合CepheidK263054BIOFIRE 呼吸面板 2.1 (RP2.1)Biofire DiagnosticsK261837FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K252932快速PCR迷你呼吸道面板Autonomous Medical Devices IncorporatedK252269FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K251742VELO 呼吸測試Lex Diagnostics Limited

官方來源

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