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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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LABScreen™ PRA Class I - Sample - 00812117018867

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018867 ()
LS1PRAS

  • HLA class I & II antibody screening IVD, kit, multiplex

LABScreen™ Single Antigen HLA Class I Supplement - Group 1 - 00812117018850

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018850 ()
LS1ASP01

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Single Antigen Class I - 00812117018706

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018706 ()
LATP1HD

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I - 00812117018683

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018683 ()
LATP140

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - 00812117018676

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018676 ()
LATP1288

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - 00812117018669

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018669 ()
LATP1240

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Mixed Class I & II - 00812117018652

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018652 ()
LATM20X5P

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Mixed Class I & II - 00812117018638

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018638 ()
LATM10X5P

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Single Antigen Class I - Sample - 00812117018560

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018560 ()
LAT1HDS

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - Sample - 00812117018546

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018546 ()
LAT1288S

  • HLA class I & II antibody screening IVD, kit, multiplex
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