FDA 510(k)

生物火COVID-19測試2

K 號：K221460 · 2022-07-25

決定日期2022-07-25

產品代碼QQX

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 COVID-19 Test 2 is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2022-07-25 under 510(k) number K221460. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioFire COVID-19 Test 2?

BioFire COVID-19 Test 2 is a medical device that received FDA 510(k) clearance on 2022-07-25. The listed applicant is Biofire Defense, LLC. The 510(k) number is K221460.

When did BioFire COVID-19 Test 2 receive FDA 510(k) clearance?

BioFire COVID-19 Test 2 received FDA 510(k) clearance on 2022-07-25, under 510(k) number K221460.

Who is the listed applicant for BioFire COVID-19 Test 2?

FDA 510(k) 記錄將 Biofire Defense, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BioFire COVID-19 Test 2?

The FDA product code for BioFire COVID-19 Test 2 is QQX.

其他以 Biofire Defense, 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。

K261475BIOFIRE® FILMARRAY® 熱帶熱症面板控制組 K243822BioFire戰士面板；BioFire戰士面板控制套件 K213362BioFire Global 還熱特殊病原體面板；BIOFIRE SHIELD 控制組合用於BioFire Global 還熱特殊病原體面板 K220870BioFire Global 還熱試劑板，BIOFIRE SHIELD 控制組合用於BioFire Global 還熱試劑板 K211079生物火COVID-19測試2 K202382FilmArray全球發燒面板外部控制組合包

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相關器械（代碼：QQX）

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。

K243396Aptima SARS-CoV-2 檢測試劑Hologic, Inc.K240867cobas® SARS-CoV-2 定性檢測用於 cobas® 5800/6800/8800 系統Roche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular K233453Applied Biosystems™ TaqPath™ COVID-19 诊断PCR試劑套件Life Technologies Corporation K230440Xpert® Xpress CoV-2 plusCepheid®

官方來源

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