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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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The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system
ONE LAMBDA, INC.
UTPCDX-PGR
In Commercial Distribution

  • 00812117016849 ()
UTPCDX-PGR

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016832 ()
LKTB25

  • Cell centrifugation/density gradient separation reagent IVD
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-GSSP
In Commercial Distribution

  • 00812117016825 ()
SECCDX-GSSP

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-A
In Commercial Distribution

  • 00812117016818 ()
SECCDX-A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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
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™ 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
Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016474 ()
SSPT2-G2

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016467 ()
SSPT1-F2

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016450 ()
SSPT1-E2

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