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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 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

LABType™ CWD Class II DRB1 Locus Typing - 00814695022748

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

  • 00814695022748 ()
RSOW2B1T

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

LABType™ CWD Class I C Locus Typing Test - 00814695022731

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

  • 00814695022731 ()
RSOW1CT

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

LABType™ CWD Class I B Locus Typing Test - 00814695022724

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

  • 00814695022724 ()
RSOW1BT

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

LABType™ CWD Class I A Locus Typing Test - 00814695022717

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

  • 00814695022717 ()
RSOW1AT

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

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™ 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

AllSet+™ Gold SSP DQ Low Resolution Kit - 00814695022489

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

  • 00814695022489 ()
54390D

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

AllSet+™ Gold SSP DRDQ Low Resolution Kit - 00814695022472

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

  • 00814695022472 ()
54380D

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