FDA 510(k)

BD Veritor 系統快速檢測流感 A + B CLIA 豁免套件

K 號：K160161 · 2016-02-24

決定日期2016-02-24

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

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K160161. 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 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K160161.

When did BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit receive FDA 510(k) clearance?

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit received FDA 510(k) clearance on 2016-02-24, under 510(k) number K160161.

Who is the listed applicant for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

The FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is PSZ.

其他以 Becton, Dickinson & CO 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。

K160164BD Veritor 系統快速檢測流感 A + B 实驗室套件

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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