24 results
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49ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Accelerate PhenoTest™ BC Kit
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·00862011000307·The Accelerate PhenoTest™ BC kit is a multiplex...
Accelerate PhenoTest BC kit
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·00862011000383·The Accelerate PhenoTest® BC kit is a multiplex...
Accelerate PhenoTest® BC AST QC test
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·00862011000352·The Accelerate PhenoTest® BC AST QC test is int...
Accelerate Pheno™ System
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·00862011000314·The Accelerate Pheno™ system is a fully-integra...
Accelerate Pheno™ System
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·00862011000321·The Accelerate Pheno™ system is a fully-integra...
Accelerate PhenoTest® BC kit
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·00862011000369·The Accelerate PhenoTest® BC kit is a multiplex...
Accelerate PhenoTest BC ID QC test
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·10862011000335·The Accelerate PhenoTest™ BC ID QC test is inte...
Accelerate PhenoTest BC AST QC test
FDA UDI
ACCELERATE DIAGNOSTICS, INC.·10862011000342·The Accelerate PhenoTest™ BC AST QC test is int...
ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT
FDA Adverse Event
Malfunction
·ACCELERATE DIAGNOSTICS, INC.·Product code PRH·October 23, 2019
ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT
FDA Adverse Event
Malfunction
·ACCELERATE DIAGNOSTICS, INC.·Product code PRH·March 17, 2020
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits.
FDA Recall
Terminated
·Accelerate Diagnostics Inc·Product code PRH·March 13, 2017
Accelerate PhenoTest BC kit REF 10102018
FDA Recall
Open, Classified
·Accelerate Diagnostics Inc·Product code PRH·October 17, 2022
Accelerate PhenoTest BC kit REF 10101018
FDA Recall
Open, Classified
·Accelerate Diagnostics Inc·Product code PRH·October 17, 2022
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Recall
Terminated
·Accelerate Diagnostics Inc·Product code PRH·March 14, 2018
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·February 10, 2023
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
FDA Enforcement
Class III
·Terminated·Cardiocommand Inc.·June 19, 2019
AVANTI J-30I CENTRIFUGE
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JQC·June 30, 2008
Accelerate PhenoTest BC kit REF 10101018
FDA Enforcement
Class II
·Ongoing·Accelerate Diagnostics Inc·December 7, 2022
Accelerate PhenoTest BC kit REF 10102018
FDA Enforcement
Class II
·Ongoing·Accelerate Diagnostics Inc·December 7, 2022
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Enforcement
Class II
·Terminated·Accelerate Diagnostics Inc·May 2, 2018