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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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LABType™ SSO Class I B Locus Typing Test - 1000 tests - 00812117017884

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

  • 00812117017884 ()
RSSO1BX

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

LABType™ SSO Class I A Locus Typing Test - 1000 tests - 00812117017877

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

  • 00812117017877 ()
RSSO1AX

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

AllSet+™ Gold SSP B Locus High Resolution Kit - 00812117017839

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017839 ()
54020D

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

AllSet+™ Gold SSP A Locus High Resolution Kit - 00812117017822

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017822 ()
54010D

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

SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017563

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

  • 00812117017563 ()
A15573

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

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*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
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