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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LeadCare® II Blood Lead Testing System 9X Test Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® II
In Commercial Distribution

  • 00850355006093 ()
70-9000

  • Lead (Pb) analyser IVD
LeadCare® II Test Kit 5X Test Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® II
In Commercial Distribution

  • 00850355006086 ()
70-8404

  • Lead (Pb) analyser IVD
LeadCare® II Blood Lead 6 Tests Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® II
In Commercial Distribution

  • 00850355006079 ()
70-7142

  • Lead (Pb) analyser IVD
LeadCare® Plus Blood Lead Analyzer Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® Plus
In Commercial Distribution

  • 00850355006062 ()
82-0001

  • Lead (Pb) analyser IVD
LeadCare® Ultra Blood Lead Testing System
MAGELLAN DIAGNOSTICS, INC.
LeadCare® Ultra
In Commercial Distribution

  • 00850355006055 ()
70-8040

  • Lead (Pb) analyser IVD
LeadCare® Ultra Blood Lead Analyzer Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® Ultra
In Commercial Distribution

  • 00850355006048 ()


  • Lead (Pb) analyser IVD
LeadCare® Plus Blood Lead Test Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® Plus
In Commercial Distribution

  • 00850355006031 ()
82-0004

  • Lead (Pb) analyser IVD
LeadCare® Ultra Blood Lead Test Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® Ultra
In Commercial Distribution

  • 00850355006024 ()
70-8098

  • Lead (Pb) analyser IVD
LeadCare® II Blood Lead Analyzer Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® II
In Commercial Distribution

  • 00850355006017 ()
70-6760

  • Lead (Pb) analyser IVD
LeadCare® II Blood Lead Test Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare® II
In Commercial Distribution

  • 00850355006000 ()
70-6762

  • Lead (Pb) analyser IVD
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