FDA 510(k)

索菲亞萊姆FIA；索菲亞2攝氏菌FIA

K 號：K254295 · 2026-07-10

申請人Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

決定日期2026-07-10

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 Lyme FIA; Sofia 2 Campylobacter FIA is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K254295. 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 Lyme FIA; Sofia 2 Campylobacter FIA?

Sofia Lyme FIA; Sofia 2 Campylobacter FIA is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). The 510(k) number is K254295.

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

Sofia Lyme FIA; Sofia 2 Campylobacter FIA received FDA 510(k) clearance on 2026-07-10, under 510(k) number K254295.

Who is the listed applicant for Sofia Lyme FIA; Sofia 2 Campylobacter FIA?

FDA 510(k) 記錄將 Ortho-Clinical Diagnostics, Inc.（QuidelOrtho）列為申請人。這並不單獨確立設備製造商。

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

The FDA product code for Sofia Lyme FIA; Sofia 2 Campylobacter FIA is LSR.

其他以 Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) 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。

K254264Sofia 2 SARS 抗原+ FIA；Sofia 2 犬纏虫 FIA K254262索菲亞流感A+B FIA；索菲亞呼吸道合胞病毒FIA；索菲亞溶血性链球菌A+ FIA

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。

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官方來源

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