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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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ToRC IgG Control Set
BIO-RAD LABORATORIES, INC.
6631630
In Commercial Distribution

  • 00847865000420 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
6631630

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002158 ()

  • 1 Each
6651665D

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Anti-Human Globulin Anti-IgG is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG. Anti-Human Globulin Anti-IgG is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG.
ALBA BIOSCIENCE LIMITED
Z357U
In Commercial Distribution

  • 05060242472411 ()
  • 05060242472404 ()
  • 05060242472428 ()
  • 05060242472435 ()


  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Anti-Human Globulin, Anti-IgG, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG. Anti-Human Globulin, Anti-IgG, is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG.
ALBA BIOSCIENCE LIMITED
Z356U
In Commercial Distribution

  • 05060242471605 ()
  • 05060242471629 ()
  • 05060242471599 ()
  • 05060242471582 ()


  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
MTS Anti-IgG Card
MICRO TYPING SYSTEMS, INC
MTS084024
In Commercial Distribution

  • 10758750005994 ()
MTS084024

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
ANTI-IGG GRN 1X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716760
In Commercial Distribution

  • 10758750003594 ()
716760

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
ANTI-IGG GRN 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716700
In Commercial Distribution

  • 10758750003587 ()
716700

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
ANTI-IGG 1X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716360
In Commercial Distribution

  • 10758750003556 ()
716360

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
ANTI-IGG 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716300
In Commercial Distribution

  • 10758750003549 ()
716300

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
The DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and 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
210394
In Commercial Distribution

  • 08437014205060 ()
210394

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
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