FDA 510(k)

Sofia 2 狸蟲病 FIA，Sofia 狸蟲病控制組

K 號：K173496 · 2018-08-30

決定日期2018-08-30

產品代碼LSR

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 Lyme FIA, Sofia Lyme Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2018-08-30 under 510(k) number K173496. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sofia 2 Lyme FIA, Sofia Lyme Control Set?

Sofia 2 Lyme FIA, Sofia Lyme Control Set is a medical device that received FDA 510(k) clearance on 2018-08-30. The listed applicant is Quidel Corporation. The 510(k) number is K173496.

When did Sofia 2 Lyme FIA, Sofia Lyme Control Set receive FDA 510(k) clearance?

Sofia 2 Lyme FIA, Sofia Lyme Control Set received FDA 510(k) clearance on 2018-08-30, under 510(k) number K173496.

Who is the listed applicant for Sofia 2 Lyme FIA, Sofia Lyme Control Set?

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 Lyme FIA, Sofia Lyme Control Set?

The FDA product code for Sofia 2 Lyme FIA, Sofia Lyme Control Set is LSR.

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 K211342Sofia 2 萎縮菌 FIA

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相關器械（代碼：LSR）

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。

K254295索菲亞萊姆FIA；索菲亞2攝氏菌FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG測試；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot 套件Id-Fish Technology, Inc.K233367iDart Lyme IgG 免疫Blot 套件Id-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 控制組合Zeus Scientific K220016維拉美德 Borrela 全功能 ViraChip 檢測套件Viramed Biotech AG

官方來源

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