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FDA 510(k)

ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試, ADVIA Centaur Active-B12(AB12) 質量控制，以及 ADVIA Centaur Active-B12 (AB12) 主曲線材料 (MCM)

K 號：K160757 · 2016-07-26

申請人Axis-Shield Diagnostics Limited
決定日期2016-07-26
產品代碼CDD
諮詢委員會CH
決定相當於

器材摘要

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160757. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K160757.

When did ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) receive FDA 510(k) clearance?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160757.

Who is the listed applicant for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

The FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is CDD.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Axis-Shield Diagnostics Limited 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。

K183088ADVIA Centaur 紅血球生成素 (EPO) 測試K182012ADVIA Centaur 骨髄素 (CALCT) 測試K153551ADVCentaur Anti-CCP IgG (aCCP)試劑包括反應劑、校準劑、質控品及標準曲線材料。

相關器械（代碼：CDD）

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。

K233541ARCHITECT Active-B12 (全轉運型葉酸鹽)Axis-Shield Diagnostics, Ltd.K223289Access 鎘B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 免疫測定系統，Access 鐵蛋白測試，Access 叶酸測試，Access 促甲状腺激素（第3代國際標準品），Access B12維生素Beckman Coulter Biomedical GmbHK192064聯盟維生素B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試Axis-Shield Diagnostics, Ltd.K161721迪亞茲美維生素B12測試，迪亞茲美維生素B12校准器組，迪亞茲美維生素B12控制組Diazyme Laboratories

官方來源

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