FDA 510(k)

索拉納GBS檢測試劑

K 號：K173250 · 2017-12-21

決定日期2017-12-21

產品代碼NJR

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 GBS 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 2017-12-21 under 510(k) number K173250. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Solana GBS Assay?

Solana GBS Assay is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Quidel Corporation. The 510(k) number is K173250.

When did Solana GBS Assay receive FDA 510(k) clearance?

Solana GBS Assay received FDA 510(k) clearance on 2017-12-21, under 510(k) number K173250.

Who is the listed applicant for Solana GBS 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 GBS Assay?

The FDA product code for Solana GBS Assay is NJR.

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。

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相關器械（代碼：NJR）

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。

K222638Xpert® Xpress GBS、GeneXpert® Dx 系統、GeneXpert® Infinity 系統Cepheid K203429Xpert GBS LB XC，GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid K182467Simplexa GBS 直接，Simplexa GBS 阳性控制組合包Diasorin Molecular, LLC K181156山貓融合GBS試劑Diagenode K173725NeuMoDx GBS 檢測Neumodx Molecular, Inc.K170557基因POC GBS LBGenepoc, Inc.

官方來源

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