FDA 510(k)

BD Veritor システムフル A + B 流感の迅速検出用 CLIA 免許証不要キット

K番号: K180438 · 2018-03-20

申請者Bd

決定日2018-03-20

製品コードPSZ

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてBdを記載するその他の記録

K253445BD Surgiphor™ 1000 mL 抗菌灌洗システム（910120）K240257デナリ™ ヴェナ・カヴァ・フィルターシステム – フェマルおよび jugular/subclavian デリバリーキット K232434BD Veritor™ フル速診断インフルエンザA+B キット（CLIA無認可）K223016BD Veritor™ システムフル速報型インフルエンザA+B検出用CLIA-Waivedキット K221504BD Surgiphor™ 抗菌灌洗システム

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