FDA 510(k)

Sofia 2 萎縮菌 FIA

K 號：K211342 · 2021-11-23

決定日期2021-11-23

產品代碼LQP

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

Sofia 2 Campylobacter FIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211342. The device is classified under product code LQP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sofia 2 Campylobacter FIA?

Sofia 2 Campylobacter FIA is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Quidel Corporation. The 510(k) number is K211342.

When did Sofia 2 Campylobacter FIA receive FDA 510(k) clearance?

Sofia 2 Campylobacter FIA received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211342.

Who is the listed applicant for Sofia 2 Campylobacter FIA?

The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sofia 2 Campylobacter FIA?

The FDA product code for Sofia 2 Campylobacter FIA is LQP.

其他以 Quidel Corporation 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。

K231795QuickVue COVID-19 測試 K232286薩凡納HSV 1+2/VZV檢測，薩凡納HSV 1+2/VZV控制組，薩凡納儀器 K233688Sofia 2 SARS 抗原+ FIA；Sofia 2 SARS 抗原+ FIA 控制拭子組 K230349萊拉RSV+hMPV檢測試劑 K230236麗拉A+B型流感檢測試劑 K173496Sofia 2 狸蟲病 FIA，Sofia 狸蟲病控制組

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相關器械（代碼：LQP）

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。

K210976Curian CampyMeridian Bioscience, Inc.K191456卡姆披氏菌快速檢測Techlab, Inc.K191442卡姆披氏菌檢測器Techlab, Inc.K173217卡姆洛巴菌快檢Techlab, Inc.K173219卡姆洛巴菌檢測器Techlab, Inc.

官方來源

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