FDA 510(k)

Alinity m HSV 1 & 2 / VZV

K 號：K233349 · 2024-05-03

決定日期2024-05-03

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

Alinity m HSV 1 & 2 / VZV is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K233349. 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 Alinity m HSV 1 & 2 / VZV?

Alinity m HSV 1 & 2 / VZV is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K233349.

When did Alinity m HSV 1 & 2 / VZV receive FDA 510(k) clearance?

Alinity m HSV 1 & 2 / VZV received FDA 510(k) clearance on 2024-05-03, under 510(k) number K233349.

Who is the listed applicant for Alinity m HSV 1 & 2 / VZV?

The FDA 510(k) record lists Abbott Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity m HSV 1 & 2 / VZV?

The FDA product code for Alinity m HSV 1 & 2 / VZV is PGI.

其他以 Abbott Molecular, Inc. 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。

K252102Alinity m HCV K243489Alinity m EBV (09N43-095)K243485Alinity m CMV K241921Alinity m BKV K241573Alinity m Resp-4-Plex K222379Alinity m STI Assay

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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。

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Quidel Corporation 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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