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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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Brasseler USA - 00887919972075

WIRELE-X APEX LOCATOR
Peter Brasseler Holdings, LLC
5030838U0
In Commercial Distribution

  • 00887919972075 ()


  • Endodontic apex locator

PE - Conjugated Goat Anti-Human IgG (100X) - 00812117019109

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117019109 ()
LSPSAB2

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

LABScreen™ Multi - Sample - 00812117018935

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018935 ()
LSMUTRS

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

LABScreen™ PRA Class II - Group 1 Sample - 00812117018898

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018898 ()
LS2PRAS

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

LABScreen™ PRA Class I - Sample - 00812117018867

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018867 ()
LS1PRAS

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

LABScreen™ Single Antigen HLA Class I - Combi - Sample - 00812117018843

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018843 ()
LS1A04S

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

Lambda Monoclonal Trays™ HLA Class I (Black) - 00812117018812

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

  • 00812117018812 ()
LMBL72

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

Lambda Cell Tray™ 60 T Cell Panel - Sample - 00812117018751

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

  • 00812117018751 ()
LCT1W60S

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

Lambda Antigen Tray™ Single Antigen Class I - 00812117018706

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

  • 00812117018706 ()
LATP1HD

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

Lambda Antigen Tray™ Class I - 00812117018690

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

  • 00812117018690 ()
LATP140X2

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