FDA 510(k)

Acucy 開放性流感 A&B 檢測與 Acucy 系統

K 號：K182001 · 2018-12-17

決定日期2018-12-17

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 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 2018-12-17 under 510(k) number K182001. 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 System?

Acucy Influenza A&B Test with the Acucy System is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K182001.

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

Acucy Influenza A&B Test with the Acucy System received FDA 510(k) clearance on 2018-12-17, under 510(k) number K182001.

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

The FDA product code for Acucy Influenza A&B Test with the Acucy 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。

K241188Acucy® 開放性流感 A&B 檢測與 Acucy® 2 系統 K192719Osom Ultra Plus 流感A&B檢測套件 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.K241188Acucy® 開放性流感 A&B 檢測與 Acucy® 2 系統SEKISUI Diagnostics, LLC 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

官方來源

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