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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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Freeze Dried Papain is used as a proteolytic enzyme in serological tests. The papain enzyme is derived from Carica papaya. The product configuration is ten (10) vials.
IMMUCOR, INC.
0057292
In Commercial Distribution

  • 10888234000990 ()
0057292

  • Papain immunohaematology reagent IVD
Complement Control Cells are used in confirming reactivity of the anti-C3 component of Anti-Human Globulin, as a control mechanism for the antiglobuilin test. This product is a one (1) vial configuration.
IMMUCOR, INC.
0007930
In Commercial Distribution

  • 10888234000914 ()
0007930

  • Complement components C3/C3c IVD, control
Gamma-Quin is intended for use in removing red cell-bound immunoglobulin. Gamma-Quin is an approximately 16% solution of chloroquine diphosphate in phosphate-buffered saline at a pH of about 5.0. This package configuration is one (1) vial of 10 mL volume.
IMMUCOR, INC.
0007890
In Commercial Distribution

  • 10888234000891 ()
0007890

  • Immunoglobulin removal reagent IVD
Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution

  • 10888234000846 ()
0007700

  • Immunoglobulin removal reagent IVD
Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0007151
In Commercial Distribution

  • 10888234000723 ()
0007151

  • Anti-H red blood cell grouping IVD, lectin
GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007058
In Commercial Distribution

  • 10888234000716 ()
0007058

  • Bromelin immunohaematology reagent IVD
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration.
IMMUCOR, INC.
0006428
In Commercial Distribution

  • 10888234000600 ()
0006428

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
IMMUCOR, INC.
0006427
In Commercial Distribution

  • 10888234000594 ()
0006427

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set.
IMMUCOR, INC.
0002417
In Commercial Distribution

  • 10888234000341 ()
0002417

  • Multiple immunohaematology test IVD, control
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