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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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Optilite® IgG2 Control Pack - 05051700018920

No Description
THE BINDING SITE GROUP LIMITED
NQ007.OPT
In Commercial Distribution

  • 05051700018920 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Optilite® IgG1 Control Pack - 05051700018913

No Description
THE BINDING SITE GROUP LIMITED
NQ006.OPT
In Commercial Distribution

  • 05051700018913 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Human IgG Subclass Control Pack for use on the SPAPLUS® - 05051700018593

No Description
THE BINDING SITE GROUP LIMITED
NQ006.S
Not in Commercial Distribution

  • 05051700018593 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Optilite® IgG3 Control Pack - 05051700018579

No Description
THE BINDING SITE GROUP LIMITED
NQ008.OPT
In Commercial Distribution

  • 05051700018579 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Optilite® IgG4 Control Pack - 05051700018562

No Description
THE BINDING SITE GROUP LIMITED
NQ009.OPT
In Commercial Distribution

  • 05051700018562 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Trinity Biotech - 05391516748810

Uni-Gold™ S. pneumoniae, 20 Tests
MARDX DIAGNOSTICS, INC.
1204420
In Commercial Distribution

  • 05391516748810 ()
1204420

  • Streptococcus pneumoniae immunoglobulin G (IgG) antibody IVD, kit, multiplex

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

LIAISON® VCA IgG Serum Control Set - 08056771601771

No Description
DIASORIN SPA
310512
Not in Commercial Distribution

  • 08056771601771 ()


  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control Borrelia burgdorferi - 08056771600279

No Description
Diasorin Inc.
310871
In Commercial Distribution

  • 08056771600279 ()


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

LIAISON® Control VZV IgG HT - 08056771104173

No Description
DIASORIN SPA
311871
In Commercial Distribution

  • 08056771104173 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
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