FDA 510(k)

BD 阴道面板

K 號：K223653 · 2023-03-06

決定日期2023-03-06

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 Vaginal Panel is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K223653. 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 Vaginal Panel?

BD Vaginal Panel is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K223653.

When did BD Vaginal Panel receive FDA 510(k) clearance?

BD Vaginal Panel received FDA 510(k) clearance on 2023-03-06, under 510(k) number K223653.

Who is the listed applicant for BD Vaginal Panel?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Vaginal Panel?

The FDA product code for BD Vaginal Panel is PQA.

其他以 Becton, Dickinson and Company 為申請人之記錄

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。

K262163BD BBL穆勒-金頓II培養基（陽離子調整）；BD Difco穆勒-金頓培養基 K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒 K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器 K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管 K260184Onclarity™ 自取樣套件 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管

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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 Company K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP；GeneXpert Xpress 系統Cepheid K221160Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid K212213Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid

官方來源

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