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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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Terasaki HLA Class II Dry Tissue Typing Tray - 00812117015279

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015279 ()
DR72D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Lyophilized Class I Complement - 00812117014340

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014340 ()
CABC-1D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Lambda Antigen Tray™ Single Antigen Class I - 00812117012537

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

  • 00812117012537 ()
LAT1HD

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

Lambda Antigen Tray™ - Mixed Class I & II - 00812117012520

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

  • 00812117012520 ()
LATM20X5

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

Lambda Antigen Tray™ - Mixed Class I & II - 00812117012513

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

  • 00812117012513 ()
LATM10X5

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

Lambda Antigen Tray™ - Mixed Class I - 00812117012506

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

  • 00812117012506 ()
LATM120

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

Lambda Antigen Tray™ Class I & II - 00812117012490

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

  • 00812117012490 ()
LAT1288

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

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 - 1 test tray - 00812117012452

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

  • 00812117012452 ()
LAT140

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

ARK™ Methotrexate Assay - 00812101030639

The ARK Methotrexate Assay c-Pack (cobas c pack green reagent packs) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-03
In Commercial Distribution

  • 00812101030639 ()
5026-0001-03

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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