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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 - Sample - 00812117018553

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

  • 00812117018553 ()
LAT140S

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB5 - 00812117016177

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

  • 00812117016177 ()
SSPR2-5

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*13 - 00812117016153

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

  • 00812117016153 ()
SSPR2-113

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*07/09/10 - 00812117016139

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

  • 00812117016139 ()
SSPR2-107

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB3 - 00812117016115

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

  • 00812117016115 ()
SSPR2-3

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*47 - 00812117016092

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

  • 00812117016092 ()
SSPR1-47

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB3 - 00812117015972

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

  • 00812117015972 ()
SSPR2-3

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*18 - 00812117015958

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

  • 00812117015958 ()
SSPR1-18

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*45 - 00812117015927

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

  • 00812117015927 ()
SSPR1-45

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*07 - 00812117015712

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

  • 00812117015712 ()
SSPR1-07

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