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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™ A Locus Sequencing Kit - 00814695021697

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

  • 00814695021697 ()
5300025

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

LABType™ SAPE Buffer - 00814695020461

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

  • 00814695020461 ()
LTSPSAPBU

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

LABType™ SAPE Buffer - 00814695020454

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

  • 00814695020454 ()
LTSPSAPBR

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

Micro SSP™ AmbiStrips™ HLA Class I - A6811N - 00814695022816

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

  • 00814695022816 ()
SSPT1-H4

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

Micro SSP™ AmbiStrips™ HLA Class I - B1501N - 00814695022809

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

  • 00814695022809 ()
SSPT1-G4

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

Micro SSP™ AmbiStrips™ HLA Class I - A0104N+A0321N+A2411N - 00814695022793

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

  • 00814695022793 ()
SSPT1-A3

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

LABType™ XR Class II DRB1 Locus Typing - 00814695022786

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022786 ()
RSOX2B1T

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

LABType™ XR Class I C Locus Typing Test - 00814695022779

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022779 ()
RSOX1CT

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

LABType™ XR Class I B Locus Typing Test - 00814695022762

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022762 ()
RSOX1BT

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

LABType™ XR Class I A Locus Typing Test - 00814695022755

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022755 ()
RSOX1AT

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