FDA 510(k)

NxTAG 呼吸器病原体パネル v2（NxTAG RPP v2）

K番号: K231758 · 2024-03-11

決定日2024-03-11

製品コードQOF

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

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K231758. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K231758.

When did NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) receive FDA 510(k) clearance?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) received FDA 510(k) clearance on 2024-03-11, under 510(k) number K231758.

Who is the listed applicant for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

The FDA 510(k) record lists Luminex Molecular Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

The FDA product code for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is QOF.

申請者としてLuminex Molecular Diagnostics, Inc.を記載するその他の記録

K242613NxTAG® 呼吸器病原体パネル K193167NxTAG呼吸病原体パネル、NxTAG呼吸病原体パネルファイル、SYNCTソフトウェア K191161xTAG Gastrointestinal Pathogen Panel (GPP)K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

すべての10件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。