FDA 510(k)

Acucy® 開放性流感 A&B 檢測與 Acucy® 2 系統

K 號：K241188 · 2025-04-18

決定日期2025-04-18

產品代碼PSZ

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

Acucy® Influenza A&B Test with the Acucy® 2 System is the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K241188. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Acucy® Influenza A&B Test with the Acucy® 2 System?

Acucy® Influenza A&B Test with the Acucy® 2 System is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K241188.

When did Acucy® Influenza A&B Test with the Acucy® 2 System receive FDA 510(k) clearance?

Acucy® Influenza A&B Test with the Acucy® 2 System received FDA 510(k) clearance on 2025-04-18, under 510(k) number K241188.

Who is the listed applicant for Acucy® Influenza A&B Test with the Acucy® 2 System?

The FDA 510(k) record lists SEKISUI Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acucy® Influenza A&B Test with the Acucy® 2 System?

The FDA product code for Acucy® Influenza A&B Test with the Acucy® 2 System is PSZ.

其他以 SEKISUI Diagnostics, 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。

K192719Osom Ultra Plus 流感A&B檢測套件 K182001Acucy 開放性流感 A&B 檢測與 Acucy 系統 K181436OSOM單一測試；Sure Vue Signature單一；ImmunoCard STAT單一；Cardinal Health Mono II快速測試

相關器械（代碼：PSZ）

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。

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+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K252283奈諾檢流感A+B檢測試劑Nano-Ditech Corporation K250398Innovita 流感A/B 抗原快速檢測Innovita (Tangshan) Biological Technology Co., Ltd.K232434BD Veritor™ 系統快速檢測流感A+B CLIA Waived KitBd K223016BD Veritor™ 系統快速檢測流感A+B CLIA-Waived KitBd K192719Osom Ultra Plus 流感A&B檢測套件SEKISUI Diagnostics, LLC

官方來源

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