2 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
FDA Enforcement
Class III
·Terminated·Critical Diagnostics·July 25, 2012
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.
FDA Enforcement
Class III
·Terminated·GE Healthcare, LLC·July 3, 2019