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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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ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0082
In Commercial Distribution

  • 00816784020390 ()
2015-0082

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
No Description
MONOBIND, INC.
1425-300
In Commercial Distribution

  • 00816870021102 ()

  • Width: 7.75 Inch
1425-300A

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G-5
In Commercial Distribution

  • 20816101022018 ()
EL0300G-5

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G
In Commercial Distribution

  • 20816101022001 ()
EL0300G

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum sample or to evaluate paired sera, by an Enzyme-Linked Immunosorbent Assay (ELISA).
SAVYON DIAGNOSTICS LTD
A111-01
In Commercial Distribution

  • 07290001913147 ()
A111-01

  • Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
PneumoTrol (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00129
In Commercial Distribution

  • 00847661002734 ()
00129

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control
  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, control
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control
The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210391
Not in Commercial Distribution

  • 08437014205053 ()
210391

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
No Description
THE BINDING SITE GROUP LIMITED
XK003
Not in Commercial Distribution

  • 05051700011235 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
XK001
Not in Commercial Distribution

  • 05051700011211 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
THE BINDING SITE GROUP LIMITED
RN012.3
Not in Commercial Distribution

  • 05051700010467 ()


  • Total immunoglobulin M (IgM total) IVD, kit, precipitation/immunodiffusion
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