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FDA 510(k)

VITROS 免疫診斷產品 NT-proBNP II 製劑包

K 號：K201312 · 2021-10-04

申請人Ortho Clinical Diagnostics
決定日期2021-10-04
產品代碼NBC
諮詢委員會CH
決定相當於

器材摘要

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K201312. 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 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack?

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K201312.

When did VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack received FDA 510(k) clearance on 2021-10-04, under 510(k) number K201312.

Who is the listed applicant for VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack?

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

What is the FDA product code for VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is NBC.

相關臨床試驗

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。

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 Ortho Clinical Diagnostics 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。

K241534VITROS 免疫診斷產品 梅毒試劑組K233581VITROS 免疫診斷產品 全 β-hCG II 製劑包K221197VITROS 免疫診斷產品 完整 PTH II 製劑包K231517維特羅斯免疫診斷產品CEA試劑包K231525VITROS 免疫診斷產品 CA 19-9TM 试剂包K221355VITROS 免疫診斷產品 CA 125 II 製劑包

查看所有 14 項裝置 →

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.K241176Alere NT-proBNP for Alinity i試劑盒Axis-Shield Diagnostics, Ltd.K232164AccessNT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.

官方來源

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