FDA 510(k)

BD MAX 阴道檢測組合

K 號：K191957 · 2019-10-21

申請人Geneohm Sciences Canada, Inc. (Bd Diagnostics)

決定日期2019-10-21

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 is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2019-10-21 under 510(k) number K191957. 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 Vaginal Panel is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K191957.

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

BD MAX Vaginal Panel received FDA 510(k) clearance on 2019-10-21, under 510(k) number K191957.

Who is the listed applicant for BD MAX Vaginal Panel?

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

What is the FDA product code for BD MAX Vaginal Panel?

The FDA product code for BD MAX Vaginal Panel is PQA.

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 K223653BD 阴道面板Becton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：PQA）

官方來源