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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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These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).
ALBA BIOSCIENCE LIMITED
Z443U
In Commercial Distribution

  • 05060242472336 ()
  • 05060242472329 ()
  • 05060242472343 ()
  • 05060242472350 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
AMERICAN NATIONAL RED CROSS
510400/510402
In Commercial Distribution

  • 20858400005095 ()
  • 00858400005091 ()
  • 10858400005098 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
Leishmania species, 6 Well Slide, 8 each pack
MARDX DIAGNOSTICS, INC.
20-04006
In Commercial Distribution

  • 05391516748919 ()
20-04006

  • Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Lyme Negative Control, 250 uL
MARDX DIAGNOSTICS, INC.
32-5001
In Commercial Distribution

  • 05391516748902 ()
32-5001

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Leismaniasis IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
20-04648
In Commercial Distribution

  • 05391516748698 ()
20-04648

  • Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Captia™ Herpes Simplex Virus 2 (HSV 2) IgG
CLARK LABORATORIES, INC.
2325501
In Commercial Distribution

  • 05391516747042 ()

  • 480 Tests
2325501

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Herpes Simplex Virus 1 (HSV1) IgG
CLARK LABORATORIES, INC.
2325401
In Commercial Distribution

  • 05391516747028 ()

  • 480 Tests
2325401

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Toxoplasma gondii IgG
CLARK LABORATORIES, INC.
2325101
In Commercial Distribution

  • 05391516746960 ()

  • 480 Tests
2325101

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ HSV 2 Type Specific IgG
CLARK LABORATORIES, INC.
2323901
In Commercial Distribution

  • 05391516746939 ()

  • 480 Tests
2323901

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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