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

  • 00812117014951 ()
RSSOH1C

  • 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

  • 00812117014944 ()
SSPR2-Q1

  • 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

  • 00812117014937 ()
SSPR2-114

  • 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

  • 00812117014920 ()
SSPR2-111

  • 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

  • 00812117014913 ()
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

  • 00812117014906 ()
SSPR1- C15

  • 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

  • 00812117014890 ()
SSPR1- C14

  • 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

  • 00812117014883 ()
SSPR1- C12

  • 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

  • 00812117014876 ()
SSPR1-C03

  • 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

  • 00812117014869 ()
SSPR1-C08

  • 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

  • 00812117014852 ()
SSPR1-C07

  • 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

  • 00812117014845 ()
SSPR1-C06

  • 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

  • 00812117014838 ()
SSPR1-C05

  • 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

  • 00812117014821 ()
SSPR1-C04

  • 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

  • 00812117014814 ()
SSPR1-C02

  • 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

  • 00812117014807 ()
SSPR1-C01

  • 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

  • 00812117014791 ()
SSPR1-68

  • 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

  • 00812117014784 ()
SSPR1-58

  • 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

  • 00812117014777 ()
SSPR1-57

  • 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

  • 00812117014760 ()
SSPR1-48

  • 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

  • 00812117014753 ()
SSPR1-42

  • 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

  • 00812117014746 ()
SSPR1-33

  • 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

  • 00812117014739 ()
SSPR1-32

  • 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

  • 00812117014722 ()
SSPR1-31

  • 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

  • 00812117014715 ()
SSPR1-30

  • 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

  • 00812117014708 ()
SSPR1-29

  • 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

  • 00812117014692 ()
SSPR1-27

  • 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

  • 00812117014685 ()
SSPR1-15

  • 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

  • 00812117014678 ()
SSPR1-08

  • 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

  • 00812117014661 ()
SSPR1-01

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

  • 00812117014654 ()
LS2AEX01

  • HLA class I & II antibody screening 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

  • 00812117014647 ()
SSP2-NL

  • 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

  • 00812117014630 ()
SSP1-NL

  • 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

  • 00812117014579 ()
RSSOH1B

  • 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

  • 00812117014562 ()
RSSOH1A

  • 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

  • 00812117014555 ()
RSSOH2B1

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014357 ()
CDR-1D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014340 ()
CABC-1D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014333 ()
CDR-50

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014326 ()
CDR-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014319 ()
CABC-50

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014302 ()
CABC-5

  • HLA class I & II antigen tissue typing 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

  • 00812117012582 ()
LCT1W60

  • 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

  • 00812117012568 ()
LCT1W30

  • 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

  • 00812117012537 ()
LAT1HD

  • 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

  • 00812117012520 ()
LATM20X5

  • 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

  • 00812117012513 ()
LATM10X5

  • 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

  • 00812117012506 ()
LATM120

  • 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

  • 00812117012490 ()
LAT1288

  • 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

  • 00812117012483 ()
LAT1240

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