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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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Micro SSP™ High Resolution HLA Class II DNA Typing Tray - DQA1 - 00812117015309

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

  • 00812117015309 ()
SSP2HQA1

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

Micro SSP™ High Resolution HLA Class II DNA Typing Tray - DPA1/DPB1 - 00812117015293

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

  • 00812117015293 ()
SSP2HDP

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

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

PE Conjugated Goat Anti-Human IgG - 00812117015231

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

  • 00812117015231 ()
LS-AB2

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

LABScreen Negative Control - 00812117015224

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

  • 00812117015224 ()
LS-NC

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

Lambda Cell Tray™ 72 T Cell Panel - 00812117015170

Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015170 ()
LCT1W72

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

LABType™ SSO Class I Exon 4-7 Supplement Typing Test - 20 tests - 00812117015101

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

  • 00812117015101 ()
RSO1E47T

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

LABType™ HD Class II DRB1 Typing Test - 20 tests - 00812117015095

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

  • 00812117015095 ()
RSOH2B1T

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

LABType™ HD Class I C Locus Typing Test - 20 tests - 00812117015088

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

  • 00812117015088 ()
RSOH1CT

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

LABType™ HD Class I B Locus Typing Test - 20 tests - 00812117015071

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

  • 00812117015071 ()
RSOH1BT

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