7 results
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27ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·May 24, 2017
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·May 24, 2017
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·June 14, 2017
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·June 14, 2017
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·July 7, 2021
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·July 7, 2021
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
FDA Enforcement
Class I
·Terminated·Magellan Diagnostics, Inc.·July 7, 2021