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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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Tissue-Tek Genie® - 00615233008947

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8384-M250
In Commercial Distribution

  • 00615233008947 ()
8384-M250

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Tissue-Tek Genie® - 00615233008930

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8384-C010
In Commercial Distribution

  • 00615233008930 ()
8384-C010

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Atellica IM CMV IgG - 00630414246635

CMV IgG Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202208
In Commercial Distribution

  • 00630414246635 ()
11202208

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Tetanus Toxoid IgG Low Control - 05051700019606

No Description
THE BINDING SITE GROUP LIMITED
EA116.L.A
In Commercial Distribution

  • 05051700019606 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, control

Tetanus Toxoid IgG High Control - 05051700019590

No Description
THE BINDING SITE GROUP LIMITED
EA116.A
In Commercial Distribution

  • 05051700019590 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, control

ImmunoDOT Borrelia Positive Control - 00613745039053

This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.
Genbio
800-3905
In Commercial Distribution

  • 00613745039053 ()

  • 0.1 mL
3905

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

Mouse IgG3 FITC Conjugate - 10190302009485

No Description
LIFE TECHNOLOGIES CORPORATION
MG301
In Commercial Distribution

  • 10190302009485 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG3 Purified Antibody - 10190302009478

No Description
LIFE TECHNOLOGIES CORPORATION
MG300
In Commercial Distribution

  • 10190302009478 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2b APC Conjugate - 10190302009461

No Description
LIFE TECHNOLOGIES CORPORATION
MG2B05
In Commercial Distribution

  • 10190302009461 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2b R-PE Conjugate - 10190302009454

No Description
LIFE TECHNOLOGIES CORPORATION
MG2B04
In Commercial Distribution

  • 10190302009454 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control
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