FDA 510(k)

ARIES® 流感 A/B & RSV 試劑

K 號：K161220 · 2016-08-02

決定日期2016-08-02

產品代碼OCC

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® Flu A/B & RSV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K161220. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARIES® Flu A/B & RSV Assay?

ARIES® Flu A/B & RSV Assay is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Luminex Corporation. The 510(k) number is K161220.

When did ARIES® Flu A/B & RSV Assay receive FDA 510(k) clearance?

ARIES® Flu A/B & RSV Assay received FDA 510(k) clearance on 2016-08-02, under 510(k) number K161220.

Who is the listed applicant for ARIES® Flu A/B & RSV Assay?

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® Flu A/B & RSV Assay?

The FDA product code for ARIES® Flu A/B & RSV Assay is OCC.

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。

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相關器械（代碼：OCC）

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。

K262747ID NOW 間接流感A&B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原體面板 (RPP)Applied BioCode, Inc.K242613NxTAG® 呼吸道病原體檢測組合Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A&B 2Abbott Diagnostics Scarborough, Inc.K231017山貓融合AdV/hMPV/RV檢測試劑Hologic, Inc.K213822cobas Influenza A/B & RSV 遺伝子核酸檢測儀，適用於cobas Liat System系統Roche Molecular Systems, Inc.

官方來源

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