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

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

Danaher Corporation is a science and technology leader that designs, manufactures, and markets innovative products and services to professional, medical, ...

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

"The AccuTnI+3 troponin assay has been clinically proven through a large multi-center study that enrolled more than 1,900 subjects, and it is confirmed that the ...

k121 - accessdata.fda.gov

Beckman Coulter, Inc. F. Proprietary and Established Names: Access AccuTnI+3 Reagent and Access AccuTnI+3 Calibrators for use on the Access ... troponin at 3 ...

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

Beckman Coulter Inc, Brea, Calif, has received FDA 510(k) clearance for 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 ...

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 Announces FDA Clearance of New Access ...

announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 ...

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

“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 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 ...

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 ...

K121214 - 510(k) Premarket Notification - FDA

K121214 · ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM · BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR.

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 ...

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 ...

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

Your firm's “AccuTnI, hsTnI, and AccuTnI+3Product [sic] Safety ... of Troponin I assays. The Harm section of this PSR addressing the ...

News From the FDA | myadlm.org

The Food and Drug Administration (FDA) has cleared Beckman Coulter's new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series ...

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.

Beckman Coulter receives FDA approval for Access AccuTnI+3 ...

In October 2010, the FDA issued guidance to manufacturers of troponin assays as part of its efforts to modernize the performance evaluation and regulatory ...

Beckman Coulter announces FDA clearance of new Access AccuTnI ...

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

Beckman Coulter Diagnostics - 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 having a ...

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

Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. FDA for its new high-sensitivity troponin (hsTnI) ...