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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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Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 57 mL bottle version with six bottles packaged.
IMMUCOR, INC.
0066231
In Commercial Distribution

  • 10888234001218 ()
0066231

  • Low ionic-strength salt solution (LISS) immunohaematology reagent 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 one (1) vial configuration.
IMMUCOR, INC.
0066122
In Commercial Distribution

  • 10888234001102 ()
0066122

  • Multiple immunohaematology test IVD, control
Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials.
IMMUCOR, INC.
0066089
In Commercial Distribution

  • 10888234001089 ()
0066089

  • Multiple immunohaematology test IVD, control
W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials.
IMMUCOR, INC.
0057319
In Commercial Distribution

  • 10888234001010 ()
0057319

  • Papain immunohaematology reagent IVD
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0012280
In Commercial Distribution

  • 10888234000952 ()
0012280

  • Anti-A1 red blood cell grouping IVD, lectin
The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.
IMMUCOR, INC.
0007893
In Commercial Distribution

  • 10888234000907 ()
0007893

  • Foeto-maternal haemorrhage/Kleihauer test IVD, reagent
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution

  • 10888234000853 ()
0007702

  • Immunoglobulin removal reagent IVD
This reagent is used for the detection of the Di(a) antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007620
In Commercial Distribution

  • 10888234000839 ()
0007620

  • Anti-Di^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the Jka antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007601
In Commercial Distribution

  • 10888234000815 ()
0007601

  • Anti-Jk^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the Fya antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007591
In Commercial Distribution

  • 10888234000792 ()
0007591

  • Anti-Fy^a red blood cell grouping IVD, antibody
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