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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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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
This reagent is used for the detection of the K antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066451
In Commercial Distribution

  • 10888234001393 ()
0066451

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
This reagent is used for the detection of the c antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066425
In Commercial Distribution

  • 10888234001386 ()
0066425

  • Anti-C [RH004] red blood cell grouping IVD, antibody
This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066424
In Commercial Distribution

  • 10888234001379 ()
0066424

  • Anti-E [RH005] red blood cell grouping IVD, antibody
This reagent is intended for the detection of the E antigen on red blood cells. This E antigen is part of the Rhesus blood group system.
IMMUCOR, INC.
0066422
In Commercial Distribution

  • 10888234001362 ()
0066422

  • Anti-E [RH003] red blood cell grouping IVD, antibody
This reagent is used for the detection of the C antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066421
In Commercial Distribution

  • 10888234001355 ()
0066421

  • Anti-C [RH002] red blood cell grouping IVD, antibody
This reagent is intended for use in slide, tube and microplate tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0066420
In Commercial Distribution

  • 10888234001348 ()
0066420

  • Anti-Rh(D) red blood cell grouping IVD, antibody
corQC EXTEND Complete 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 five vial set.
IMMUCOR, INC.
0066297
In Commercial Distribution

  • 10888234001331 ()
0066297

  • Multiple immunohaematology test IVD, control
corQC EXTEND Standard 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 single vial product.
IMMUCOR, INC.
0066296
In Commercial Distribution

  • 10888234001324 ()
0066296

  • Multiple immunohaematology test IVD, control
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
IMMUCOR, INC.
0066251
In Commercial Distribution

  • 10888234001300 ()
0066251

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
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