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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™ XR Class II DRB1 Locus Typing Test - 00814695022700

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

  • 00814695022700 ()
RSSOX2B1

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

LABType™ XR Class I C Locus Typing Test - 00814695022694

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

  • 00814695022694 ()
RSSOX1C

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

LABType™ XR Class I B Locus Typing Test - 00814695022687

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

  • 00814695022687 ()
RSSOX1B

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

LABType™ XR Class I A Locus Typing Test - 00814695022670

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

  • 00814695022670 ()
RSSOX1A

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

LABType™ CWD Class I C Locus Typing Test - 00814695022656

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

  • 00814695022656 ()
RSSOW1C

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

LABType™ CWD Class I B Locus Typing Test - 00814695022649

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

  • 00814695022649 ()
RSSOW1B

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

SeCore™ B Locus Sequencing Kit, Single Amplification - 00814695022830

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

  • 00814695022830 ()
22110D

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

AllSet+™ Gold SSP B Low Resolution Kit - 00814695022410

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

  • 00814695022410 ()
54320D

  • 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

LABType™ HD Class I B Locus Typing Test - 00812117014579

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

  • 00812117014579 ()
RSSOH1B

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