Beckman Coulter's SARS | 合法醫療器材資訊網
![Beckman Coulter's SARS](https://i.imgur.com/6y29Lx7.jpg)
2021年3月23日—BeckmanCoulteralsorecentlylaunchedanautomatedSARS-CoV-2antigentestintheU.S.underPolicyCoftheFDA'semergencyuse ...
![Beckman Coulter's SARS](https://i.imgur.com/6y29Lx7.jpg)
Lenco Diagnostic Laboratories[1], one of New York City’s largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn, NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay’s performance and is highly satisfied with the quality of the results.
“To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York,” said Robert Boorstein, M.D., Ph.D., medical director, Lenco Diagnostics Laboratories. “This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient’s immune response to COVID-19 is affected over time. We expect that clinicians will find ...
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Substantial Equivalence Determination Decision ... | 合法醫療器材資訊網
Beckman Coulter Life Sciences Recalls DxH800 and DxH600 ... | 合法醫療器材資訊網
Beckman Coulter's Automated Blood Banking Analyzer ... | 合法醫療器材資訊網
Beckman Coulter's SARS | 合法醫療器材資訊網
Establishment Registration & Device Listing | 合法醫療器材資訊網
FDA alerts hospitals | 合法醫療器材資訊網
Premarket Approval (PMA) | 合法醫療器材資訊網
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特血液分析系統】許可證字號:衛署醫器輸字第025087號
器材品名:貝克曼庫爾特血液分析系統許可證字號:衛署醫器輸字第025087號註銷狀態:註銷日期:註銷理由:有效日期:2023/07/16發證...
![](https://i.imgur.com/6y29Lx7.jpg)
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器材品名:貝克曼庫爾特UnicelDxH800庫爾特血液分析系統許可證字號:衛署醫器輸字第021536號註銷狀態:已註銷註銷日期:2018/08/...
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特艾科爾斯流式細胞儀】許可證字號:衛部醫器輸字第028078號
器材品名:貝克曼庫爾特艾科爾斯流式細胞儀許可證字號:衛部醫器輸字第028078號註銷狀態:註銷日期:註銷理由:有效日期:2026/01/...
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特血液分析系統】許可證字號:衛部醫器輸字第031441號
器材品名:貝克曼庫爾特血液分析系統許可證字號:衛部醫器輸字第031441號註銷狀態:註銷日期:註銷理由:有效日期:2023/08/30發證...