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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™ Single Antigen HLA Class II ExPlex - 00812117014654

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

  • 00812117014654 ()
LS2AEX01

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

LABType™ HD Class I A Locus Typing Test - 00812117014562

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014562 ()
RSSOH1A

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

LABType™ HD Class II DRB1 Typing Test - 00812117014555

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014555 ()
RSSOH2B1

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

Class II Complement - 50 ml - 00812117014333

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

  • 00812117014333 ()
CDR-50

  • HLA class I & II antigen tissue typing 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 - 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

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

Micro SSP™ High Resolution HLA Class II DNA Typing Tray - 00812117011783

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011783 ()
SSP2H

  • HLA class I & II antigen tissue typing 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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