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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 polyclonal reagent is used for the detection of the K antigen (of the Kell blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004140
In Commercial Distribution

  • 10888234001836 ()
0004140

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
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.
0007537
In Commercial Distribution

  • 10888234000761 ()
0007537

  • Anti-k (KEL002) red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-k (Murine Monoclonal IgM) tube technique.
ALBA BIOSCIENCE LIMITED
Z137U
Not in Commercial Distribution

  • 05060242471216 ()


  • Anti-k (KEL002) red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBA-sera Anti-K (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z131U
Not in Commercial Distribution

  • 05060242470967 ()


  • Anti-K (KEL001) red blood cell grouping IVD, antibody
The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210225
In Commercial Distribution

  • 08436583731048 ()
210225

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
The Anti-K reagent (KEL1) is for the qualitative in vitro detection of human K positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904552
In Commercial Distribution

  • 10758750013074 ()


  • Anti-K (KEL001) red blood cell grouping IVD, antibody
Anti-k (Anti-Cellano)
ORTHO-CLINICAL DIAGNOSTICS, INC.
721030
In Commercial Distribution

  • 10758750004096 ()
721030

  • Anti-k (KEL002) red blood cell grouping IVD, antibody
ANTI-K (ANTI-KELL) 1X5ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
715150
In Commercial Distribution

  • 10758750003372 ()
715150

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
Cathepsin K Control Slides
BIO SB, INC.
BSB-9438-CS
In Commercial Distribution

  • B502BSB9438CS0 ()
BSB-9438-CS

  • Cathepsin IVD, control
The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210119
Not in Commercial Distribution

  • 08437014205084 ()
210119

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
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