FDA 510(k)

HSV 1 & 2 ELITe MGB Kit；ELITe InGenius

K 號：K180559 · 2018-10-29

決定日期2018-10-29

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

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K180559. 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 HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Elitechgroup. The 510(k) number is K180559.

When did HSV 1 & 2 ELITe MGB Kit; ELITe InGenius receive FDA 510(k) clearance?

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius received FDA 510(k) clearance on 2018-10-29, under 510(k) number K180559.

Who is the listed applicant for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

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

What is the FDA product code for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

The FDA product code for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is PGI.

其他以 Elitechgroup 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。

K171401ELITech臨床系統 BILIRUBIN 總量 4+1，ELITech臨床系統 BILIRUBIN 直接 4+1 K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I 及 ELITROL II

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.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 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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