FDA 510(k)

BD 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

K番号: K223016 · 2023-01-27

申請者Bd

決定日2023-01-27

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 VeritorTM 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 2023-01-27 under 510(k) number K223016. 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 VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Bd. The 510(k) number is K223016.

When did BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit receive FDA 510(k) clearance?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit received FDA 510(k) clearance on 2023-01-27, under 510(k) number K223016.

Who is the listed applicant for BD VeritorTM 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 VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

The FDA product code for BD VeritorTM 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）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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