FDA 510(k)

BIOFIRE FILMARRAY 熱帶熱病面板

K 號：K243463 · 2024-12-05

申請人Biofire Diagnostics, LLC (Biomerieux)

決定日期2024-12-05

產品代碼QMV

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 Tropical Fever Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC (Biomerieux). It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K243463. The device is classified under product code QMV. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOFIRE FILMARRAY Tropical Fever Panel?

BIOFIRE FILMARRAY Tropical Fever Panel is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Biofire Diagnostics, LLC (Biomerieux). The 510(k) number is K243463.

When did BIOFIRE FILMARRAY Tropical Fever Panel receive FDA 510(k) clearance?

BIOFIRE FILMARRAY Tropical Fever Panel received FDA 510(k) clearance on 2024-12-05, under 510(k) number K243463.

Who is the listed applicant for BIOFIRE FILMARRAY Tropical Fever Panel?

The FDA 510(k) record lists Biofire Diagnostics, LLC (Biomerieux) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFIRE FILMARRAY Tropical Fever Panel?

The FDA product code for BIOFIRE FILMARRAY Tropical Fever Panel is QMV.

其他以 Biofire Diagnostics, LLC (Biomerieux) 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。

K243222BIOFIRE® FILMARRAY® 肺炎檢測組合（BIOFIRE 肺炎檢測組合）；BIOFIRE® FILMARRAY® 肺炎檢測組合加值版（BIOFIRE 肺炎檢測組合加值版）

相關器械（代碼：QMV）

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。

K220870BioFire Global 還熱試劑板，BIOFIRE SHIELD 控制組合用於BioFire Global 還熱試劑板Biofire Defense, LLC

官方來源

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