FDA 510(k)

BD Veritor 系統快速檢測流感 A + B CLIA 豁免套件

K 號：K180438 · 2018-03-20

申請人Bd

決定日期2018-03-20

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 Bd. It received FDA 510(k) clearance on 2018-03-20 under 510(k) number K180438. 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 2018-03-20. The listed applicant is Bd. The 510(k) number is K180438.

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 2018-03-20, under 510(k) number K180438.

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 Bd 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 Bd 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。

K253445BD Surgiphor™ 1000 mL 抗菌灌洗系統 (910120)K240257Denali™ 靜脈閉塞器系統 – 髂總動脈及頸內/鎖骨下遞送套件 K232434BD Veritor™ 系統快速檢測流感A+B CLIA Waived Kit K223016BD Veritor™ 系統快速檢測流感A+B CLIA-Waived Kit K221504BD Surgiphor™ 抗菌灌洗系統

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

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