FDA 510(k)

SeraQuest 奈瑟氏病毒2型特異性IgG

K 號：K181514 · 2019-06-13

決定日期2019-06-13

產品代碼MYF

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

SeraQuest HSV Type 2 Specific IgG is the device name listed in this FDA 510(k) record. The listed applicant is Quest International, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K181514. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SeraQuest HSV Type 2 Specific IgG?

SeraQuest HSV Type 2 Specific IgG is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Quest International, Inc.. The 510(k) number is K181514.

When did SeraQuest HSV Type 2 Specific IgG receive FDA 510(k) clearance?

SeraQuest HSV Type 2 Specific IgG received FDA 510(k) clearance on 2019-06-13, under 510(k) number K181514.

Who is the listed applicant for SeraQuest HSV Type 2 Specific IgG?

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

What is the FDA product code for SeraQuest HSV Type 2 Specific IgG?

The FDA product code for SeraQuest HSV Type 2 Specific IgG is MYF.

其他以 Quest International, 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。

K162276SeraQuest 奇異型1特異性IgG K152353SeraQuest 奈瑟氏病毒2型特異性IgG

相關器械（代碼：MYF）

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。

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG校准器, ARCHITECT HSV-2 IgG控制Biokit, S.A.K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics K181334ADVIA Centaur 布隆氏疱疹病毒-2 IgGBiokit, S.A.K152353SeraQuest 奈瑟氏病毒2型特異性IgGQuest International, Inc.

官方來源

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