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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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SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017556

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017556 ()
A15571

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

Micro SSP™ Japanese HLA Class I and II A,B,C,DRB,DQB1 DNA Typing Tray - 00812117017198

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

  • 00812117017198 ()
SSPJPN

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*03 - 00812117016979

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

  • 00812117016979 ()
SSPR2-103

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*16/17/18 - 00812117016962

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

  • 00812117016962 ()
SSPR1-C16

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*15 - 00812117016955

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

  • 00812117016955 ()
SSPR1-C15

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*14 - 00812117016948

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

  • 00812117016948 ()
SSPR1-C14

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*12 - 00812117016931

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

  • 00812117016931 ()
SSPR1-C12

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

Micro SSP™ Generic HLA Class II DRB, DQB, DPB DNA Typing Tray - 00812117016610

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

  • 00812117016610 ()
SSPDRQP1

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

HNA Genotyping Tray - 00812117016511

For the molecular determination of neutrophil polymorphisms.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016511 ()


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

Micro SSP™ AmbiStrips™ Negative Control - 00812117016481

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

  • 00812117016481 ()
SSPT1-H1

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