FDA 510(k)

Alere NT-proBNP for Alinity i試劑盒

K 號：K241176 · 2025-01-16

決定日期2025-01-16

產品代碼NBC

諮詢委員會CH

決定相當於

器材摘要

Alere NT-proBNP for Alinity i Reagent Kit is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K241176. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alere NT-proBNP for Alinity i Reagent Kit?

Alere NT-proBNP for Alinity i Reagent Kit is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K241176.

When did Alere NT-proBNP for Alinity i Reagent Kit receive FDA 510(k) clearance?

Alere NT-proBNP for Alinity i Reagent Kit received FDA 510(k) clearance on 2025-01-16, under 510(k) number K241176.

Who is the listed applicant for Alere NT-proBNP for Alinity i Reagent Kit?

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

What is the FDA product code for Alere NT-proBNP for Alinity i Reagent Kit?

The FDA product code for Alere NT-proBNP for Alinity i Reagent Kit is NBC.

其他以 Axis-Shield Diagnostics, Ltd. 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。

K253539Alere NT-proBNP for Alinity i K233541ARCHITECT Active-B12 (全轉運型葉酸鹽)K172133ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試

相關器械（代碼：NBC）

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。

K262109AccessNT-proBNPBeckman Coulter, Inc.K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K232164AccessNT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.K223637Elecsys proBNP II, Elecsys proBNP II 即時版Roche Diagnostics

官方來源

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