FDA 510(k)

薩凡納HSV 1+2/VZV檢測，薩凡納HSV 1+2/VZV控制組，薩凡納儀器

K 號：K232286 · 2023-12-20

決定日期2023-12-20

產品代碼PGI

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

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232286. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Quidel Corporation. The 510(k) number is K232286.

When did Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument receive FDA 510(k) clearance?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232286.

Who is the listed applicant for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

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 Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

The FDA product code for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is PGI.

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 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 K173496Sofia 2 狸蟲病 FIA，Sofia 狸蟲病控制組

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相關器械（代碼：PGI）

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。

K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.K192376Simplexa VZV Swab Direct，Simplexa VZV 阳性控制組合包Diasorin Molecular, LLC K180559HSV 1 & 2 ELITe MGB Kit；ELITe InGeniusElitechgroup K173798Simplexa HSV 1 & 2 直接檢測，Simplexa HSV 1 & 2 阳性控制組包Diasorin Molecular, LLC K162451索拉那HSV 1+2/VZV檢測試劑Quidel Corporation

官方來源

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