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FDA 510(k)

BD MAX 阴道檢測板, BD MAX 系統, BD 分子採集拭子套件

K 號：K201017 · 2021-10-18

申請人Geneohm Sciences Canada, Inc. (Bd Life Sciences)
決定日期2021-10-18
產品代碼PQA
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 MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Life Sciences). It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K201017. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Life Sciences). The 510(k) number is K201017.

When did BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit receive FDA 510(k) clearance?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit received FDA 510(k) clearance on 2021-10-18, under 510(k) number K201017.

Who is the listed applicant for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

The FDA 510(k) record lists Geneohm Sciences Canada, Inc. (Bd Life Sciences) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

The FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is PQA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PQA）

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。

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD 阴道面板Becton, Dickinson and CompanyK243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP；GeneXpert Xpress 系統CepheidK223653BD 阴道面板Becton, Dickinson and CompanyK221160Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid

官方來源

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