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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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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

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

IMMULITE® Systems HPG CONTROL H.pylori IgG - 00630414989907

H.Pylori - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469596
In Commercial Distribution

  • 00630414989907 ()
LHPGCM

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

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

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
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