FDA 510(k)

BD Veritor™ フル速診断インフルエンザA+B キット（CLIA無認可）

K番号: K232434 · 2023-12-05

申請者Bd

決定日2023-12-05

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 2023-12-05 under 510(k) number K232434. 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 2023-12-05. The listed applicant is Bd. The 510(k) number is K232434.

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 2023-12-05, under 510(k) number K232434.

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 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 K180438BD 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

公式ソース

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