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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For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO TYPING TESTS and LABType XR and CWD DNA Typing Test assays.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015484 ()
LSPSAB2

  • 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

  • 00812117015309 ()
SSP2HQA1

  • 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

  • 00812117015293 ()
SSP2HDP

  • 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

  • 00812117015279 ()
DR72D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015231 ()
LS-AB2

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015224 ()
LS-NC

  • HLA class I & II antibody screening IVD, kit, multiplex
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015170 ()
LCT1W72

  • HLA class I & II antibody screening IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015101 ()
RSO1E47T

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015095 ()
RSOH2B1T

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015088 ()
RSOH1CT

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