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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™ SSO Class I B Locus Typing Test - 00812117011059

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

  • 00812117011059 ()
RSSO1B

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

LABType™ SSO Class I A Locus Typing Test - 00812117011042

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

  • 00812117011042 ()
RSSO1A

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

Fast Monoclonal Trays™ Class II - 00812117010373

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

  • 00812117010373 ()
FTDR72

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

Lambda Monoclonal Trays™ HLA Class I (Oriental) - 00812117010359

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

  • 00812117010359 ()
LM72OR

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

Lambda Monoclonal Trays™ HLA Class I - 96 well - 00812117010342

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

  • 00812117010342 ()
LM96

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

Lambda Monoclonal Trays™ Second HLA Class II - 00812117010311

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

  • 00812117010311 ()
MDR272

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

Lambda Monoclonal Trays™ First HLA Class II - 00812117010304

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

  • 00812117010304 ()
MDR172

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

Lambda Monoclonal Trays™ First HLA Class II - 60 well - 00812117010298

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

  • 00812117010298 ()
MDR160

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

MIRRAGEN® Advanced Wound Matrix - 00812005030285

Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MWM-0101
In Commercial Distribution

  • 00812005030292 ()
  • 00812005030285 ()


  • Synthetic wound matrix dressing

MIRRAGEN® Advanced Wound Matrix - 00812005030223

Resorbable Borate Glass Wound Management Device
ETS Wound Care LLC
MWM-0202
In Commercial Distribution

  • 00812005030230 ()
  • 00812005030223 ()


  • Synthetic wound matrix dressing
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