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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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Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is six (6) vials of 57 mL volume.
IMMUCOR, INC.
0066053
In Commercial Distribution

  • 10888234001072 ()
0066053

  • Cell preservation/storage/dilution solution IVD
Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume.
IMMUCOR, INC.
0066052
In Commercial Distribution

  • 10888234001065 ()
0066052

  • Cell preservation/storage/dilution solution IVD
H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials.
IMMUCOR, INC.
0057320
Not in Commercial Distribution

  • 10888234001027 ()
0057320

  • Multiple human platelet antigen (HPA) typing IVD, kit, agglutination
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
RESt (Rabbit Erythrocyte Stroma) is used to adsorb cold reactive autoagglutins such as anti-I, anti-H or anti-IH, for human serum or plasma to facilitate the resolution of serological complexities. RESt contains a saline suspension of rabbit erythrocyte stroma. This package configuration is eight (8) tube tests.
IMMUCOR, INC.
0057316
In Commercial Distribution

  • 10888234001003 ()
0057316

  • Immunoglobulin removal reagent IVD
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
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
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
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-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
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