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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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Lambda Antigen Tray™ Class I & II - 2 test tray - 00812117012483

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

  • 00812117012483 ()
LAT1240

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

Lambda Antigen Tray™ Class I - 2 test tray - 00812117012469

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

  • 00812117012469 ()
LAT140X2

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

LABScreen™ Single Antigen HLA Class I - Combi - 00812117011639

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

  • 00812117011639 ()
LS1A04

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

LABScreen™ PRA Class I & II - 00812117011585

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

  • 00812117011585 ()
LS12PRA

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

LABScreen™ PRA Class II - 00812117011578

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

  • 00812117011578 ()
LS2PRA

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

LABScreen™ Single Antigen HLA Class I ExPlex - 00812117010199

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

  • 00812117010199 ()
LS1AEX01

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

LABScreen™ Mixed Class I & II - Sample - 00812117018928

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

  • 00812117018928 ()
LSMS

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

LABScreen™ Single Antigen HLA Class II Supplement - Group 1 - 00812117018881

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

  • 00812117018881 ()
LS2ASP01

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

LABScreen™ Single Antigen HLA Class II - Group 1 Sample - 00812117018874

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

  • 00812117018874 ()
LS2A01S

  • 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
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