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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 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

  • 00812117018645 ()
LATM120P

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

  • 00812117018621 ()
LATM10SA

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

  • 00812117018546 ()
LAT1288S

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

  • 00812117017006 ()
TM72OR

  • 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

  • 00812117016962 ()
SSPR1-C16

  • 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

  • 00812117016931 ()
SSPR1-C12

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

  • 00812117016900 ()
27-06D

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