FDA 510(k)

山貓融合SARS-CoV-2/流感A/B/RSV檢測試劑

K 號：K242465 · 2024-11-15

決定日期2024-11-15

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

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K242465. 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 Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Hologic, Inc.. The 510(k) number is K242465.

When did Panther Fusion SARS-CoV-2/Flu A/B/RSV assay receive FDA 510(k) clearance?

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242465.

Who is the listed applicant for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

FDA 510(k) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay?

The FDA product code for Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is QOF.

其他以 Hologic, Inc. 為申請人之記錄

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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。

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官方來源

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