FDA 510(k)

ARIES A 群鏈球菌試劑，ARIES A 群鏈球菌試劑實驗方案文件套件

K 號：K172402 · 2017-10-30

決定日期2017-10-30

產品代碼PGX

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

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K172402. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Luminex Corporation. The 510(k) number is K172402.

When did ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit receive FDA 510(k) clearance?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172402.

Who is the listed applicant for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

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

What is the FDA product code for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

The FDA product code for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is PGX.

其他以 Luminex Corporation 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。

K253722LIAISON PLEX 消化道柔軟性試驗 K243490LIAISON PLEX 革蘭氏陽性血液培養試劑 K243013LIAISON PLEX 革蘭氏陰細菌血液培養試劑 K240627LIAISON PLEX 酵母血培養試劑 K233410LIAISON PLEX 呼吸道 Flex 檢驗試劑 K191742ARIES MRSA 試劑

查看所有 13 項裝置 →

相關器械（代碼：PGX）

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。

K260047cobas Strep A 鈾酸測試，用於 cobas Liat 系統（07341911190）；cobas Strep A 質量控制套件（07402678190）Roche Molecular Systems, Inc.K260333聯繫 NES 集團 A 醜群；聯繫 NES 集團 A 醜群控制拭子套件Diasorin Molecular, LLC K201269Accula Strep A TestMesa Biotech, Inc.K183366基因POC 链球菌AGenepoc, Inc.K173653Alere i 链球菌A 2，Alere i儀器，Alere i 链球菌A 2控制拭子套件Alere Scarborough, Inc.K173398Xpert Xpress 醫療設備議定文 Xpert Xpress 醫療設備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。