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Beckman Coulter Receives FDA Clearance of Troponin I Assay on ...


Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance ...

The Access hsTnI assay detects troponin I—a protein that is present in circulation during myocardial infarction (MI)—giving clinicians important ...

Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I ...

announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI ...

Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I ...

announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of ...

Beckman Coulter receives FDA clearance of troponin I assay on ...

Beckman Coulter, Inc., has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I ...

Beckman Coulter Receives FDA Clearance of Troponin I Assay on ...

announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of ...

Beckman Coulter Gets FDA Clearance for New Troponin I Assay for ...

Beckman Coulter Inc, Brea, Calif, has received FDA 510(k) clearance for its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system ( ...

K172783 - accessdata.fda.gov

Cardiac troponin I (cTnI). D. Type of Test: Quantitative immunoassay. E. Applicant: Beckman Coulter, Inc. F. Proprietary and Established Names: Access hsTnI. G ...

Beckman Coulter, Inc. Receives FDA Clearance for Access AccuTnI ...

“Clinicians have depended on Beckman Coulter's troponin I test for over 12 years and the new AccuTnI+3 assay has the proven performance to continue providing ...

Beckman Coulter Gets FDA Clearance for High-sensitivity Access ...

The first high-sensitivity troponin I assay available in the United States, Access hsTnI enables clinicians to provide efficiency improvements in cardiac ...

Beckman Coulter Gets FDA Clearance for AccuTnI+3 Troponin I ...

Following the June 2013 clearance of the Access AccuTnI+3 troponin I assay on Beckman Coulter's Access 2 immunoassay analyzer, the new troponin assay is now ...

Beckman Coulter Gets FDA Clearance Of New Access AccuTnI+3 ...

"Clinicians have depended on Beckman Coulter's troponin I test for over 12 years and the new AccuTnI+3 assay has the proven performance to continue providing ...

k121 - accessdata.fda.gov

Cardiac troponin I (cTnI). D. Type of Test: Quantitative paramagnetic-particle chemiluminescent immunoassay. E. Applicant: Beckman Coulter, Inc. F ...

A new day for troponin in clinical practice - healthcare-in-europe.com

Beckman Coulter's new Access AccuTnI+3 troponin I assay has received FDA clearance for its UniCel DxI series of immunoassay systems at the same time as ...

FDA Oks Beckman's AccuTnI+3 Troponin I Assay On UniCel DxI ...

Following the June 2013 clearance of the Access AccuTnI+3 troponin I assay on Beckman Coulter's Access 2 immunoassay analyzer, the new troponin assay is now ...

Beckman Coulter Diagnostics Receives CE Mark Clearance for its ...

Beckman Coulter Diagnostics announced today that it has received CE Mark clearance for a new high-sensitivity troponin (hsTnI) assay that ...

k12 - accessdata.fda.gov

Cardiac troponin I (cTnI). D. Type of Test: Quantitative paramagnetic-particle chemiluminescent immunoassay. E. Applicant: Beckman Coulter, Inc. F ...

Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance ...

"Beckman Coulter's high-sensitivity cardiac troponin I assay can measure very low cardiac troponin concentrations with excellent precision. This ...

Troponin I assay, 7/13:104 - CAP TODAY

Beckman Coulter has received FDA 510(k) clearance for its Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system.

FDA clears expanded use of troponin I test - Medscape

Fullerton, CA - Beckman Coulter, Inc has received FDA clearance to expand the clinical use of its Access® AccuTnITM troponin I test to help ...

Beckman Coulter Inc. - 678042 - 03/15/2024 - FDA

We received a response January 01, 2024, and February 15, 2024 ... troponin assay. In addition, labeling updates were made as part of ...