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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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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
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

  • 00812117012476 ()
LAT240

  • 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

  • 00812117012469 ()
LAT140X2

  • 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

  • 00812117012452 ()
LAT140

  • HLA class I & II antibody screening IVD, kit, multiplex
RESPONDER® Polysaccharide Hemostat is intended to be used to achieve hemostasis in emergency situations forthe temporary control of severe topical bleeding.
Starch Medical Inc.
RP0025
In Commercial Distribution

  • 10899010002886 ()
  • 00899010002889 ()


  • Plant polysaccharide haemostatic agent, bioabsorbable
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions.
Starch Medical Inc.
RP0003
In Commercial Distribution

  • 00899010002698 ()
  • 00899010002865 ()


  • Plant polysaccharide haemostatic agent, bioabsorbable
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