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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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This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is green.
IMMUCOR, INC.
0409210
In Commercial Distribution

  • 10888234001669 ()
0409210

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is three (3) vials of reagent. The color of the liquid reagent is green.
IMMUCOR, INC.
0409203
In Commercial Distribution

  • 10888234001652 ()
0409203

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear.
IMMUCOR, INC.
0401510
In Commercial Distribution

  • 10888234001645 ()
0401510

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear.
IMMUCOR, INC.
0401010
In Commercial Distribution

  • 10888234001638 ()
0401010

  • Monospecific anti-complement component C3d (anti-C3d) IVD, antibody
Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.
IMMUCOR, INC.
0066902
In Commercial Distribution

  • 10888234001546 ()
0066902

  • Total immunoglobulin G (IgG total) IVD, control
TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.
IMMUCOR, INC.
0066828
In Commercial Distribution

  • 10888234001508 ()
0066828

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials.
IMMUCOR, INC.
0066827
In Commercial Distribution

  • 10888234001492 ()
0066827

  • Treponema pallidum total antibody IVD, kit, agglutination
TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials.
IMMUCOR, INC.
0066826
In Commercial Distribution

  • 10888234001485 ()
0066826

  • Treponema pallidum total antibody IVD, kit, agglutination
Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum) are run controls to be used in Capture-R solid phase assays. The Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells. The Capture-R Negative Control Serum does not contain antibodies to red blood cells. This product configuration has one (1) vial of each control, at a volume of 11.5 mL each.
IMMUCOR, INC.
0066236
In Commercial Distribution

  • 10888234001225 ()
0066236

  • Solid-phase red blood cell adherence antibody/antigen IVD
DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the four (4) vial configuration.
IMMUCOR, INC.
0066125
In Commercial Distribution

  • 10888234001119 ()
0066125

  • Multiple immunohaematology test IVD, control
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