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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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Dako - 05700571104057

c-Kit pharmDx for Autostainer
AGILENT TECHNOLOGIES, INC.
K1907
Not in Commercial Distribution

  • 05700571104057 ()

  • 35 Tests


  • CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry

MAGE-A4 IHC 1F9 pharmDx - 05700573007400

MAGE-A4 IHC 1F9 pharmDx
AGILENT TECHNOLOGIES, INC.
SK032
In Commercial Distribution

  • 05700573007400 ()

  • 50 test


  • Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry

Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - 05700573004591

Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
AGILENT TECHNOLOGIES, INC.
GE020
In Commercial Distribution

  • 05700573004591 ()

  • 60 Tests


  • Ki67 antigen IVD, kit, enzyme immunohistochemistry

MONOLISA™ - 00847865013178

Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26203
In Commercial Distribution

  • 00847865013178 ()

  • Total Volume: 1.5 Milliliter
26203

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control

MONOLISA™ - 00847865013161

Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL
Bio-RAD Laboratories, Inc.
26202
In Commercial Distribution

  • 00847865013161 ()

  • Total Volume: 7.5 Milliliter
26202

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent

MONOLISA™ - 00847865013154

Anti-HBc IgM EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26201
In Commercial Distribution

  • 00847865013154 ()

  • Total Volume: 0.8 Milliliter
26201

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

MONOLISA™ - 00847865013147

Anti-HBc IgM EIA, Positive Control,1.6 mL
Bio-RAD Laboratories, Inc.
26200
In Commercial Distribution

  • 00847865013147 ()

  • Total Volume: 1.6 Milliliter
26200

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

MONOLISA™ - 00847865013130

Anti-HBc IgM EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26199
In Commercial Distribution

  • 00847865013130 ()

  • Total Volume: 30 Milliliter
26199

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent

MONOLISA™ - 00847865013123

Anti-HBc IgM EIA Conjugate Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26198
In Commercial Distribution

  • 00847865013123 ()

  • Total Volume: 30 Milliliter
26198

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent

MONOLISA™ - 00847865013116

Anti-HBc EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26197
In Commercial Distribution

  • 00847865013116 ()

  • Total Volume: 0.8 Milliliter
26197

  • Hepatitis B virus core antigen IVD, control
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