FDA 510(k)

索拉納RSV+hMPV檢測試劑

K 號：K171974 · 2017-10-16

決定日期2017-10-16

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

Solana RSV+hMPV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-10-16 under 510(k) number K171974. 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 Solana RSV+hMPV Assay?

Solana RSV+hMPV Assay is a medical device that received FDA 510(k) clearance on 2017-10-16. The listed applicant is Quidel Corporation. The 510(k) number is K171974.

When did Solana RSV+hMPV Assay receive FDA 510(k) clearance?

Solana RSV+hMPV Assay received FDA 510(k) clearance on 2017-10-16, under 510(k) number K171974.

Who is the listed applicant for Solana RSV+hMPV Assay?

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

What is the FDA product code for Solana RSV+hMPV Assay?

The FDA product code for Solana RSV+hMPV Assay is OCC.

其他以 Quidel 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。

K231795QuickVue COVID-19 測試 K232286薩凡納HSV 1+2/VZV檢測，薩凡納HSV 1+2/VZV控制組，薩凡納儀器 K233688Sofia 2 SARS 抗原+ FIA；Sofia 2 SARS 抗原+ FIA 控制拭子組 K230349萊拉RSV+hMPV檢測試劑 K230236麗拉A+B型流感檢測試劑 K211342Sofia 2 萎縮菌 FIA

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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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