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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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Tono-Pen AVIA® - 00812559010108

Handheld, battery-powered contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected.
REICHERT, INC.
230650
In Commercial Distribution

  • 00812559010108 ()


  • Ophthalmic tonometer, battery-operated

Tono-Pen® XL - 00812559010092

Handheld, battery-powered, contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected.
REICHERT, INC.
230635
In Commercial Distribution

  • 00812559010092 ()


  • Ophthalmic tonometer, battery-operated

Lambda Antigen Tray™ Class II - 00812117018713

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

  • 00812117018713 ()
LATP240

  • 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

Lambda Antigen Tray™ Class I - 00812117018683

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

  • 00812117018683 ()
LATP140

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

Lambda Antigen Tray™ Class I & II - 00812117018676

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

  • 00812117018676 ()
LATP1288

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

Lambda Antigen Tray™ Class I & II - 00812117018669

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

  • 00812117018669 ()
LATP1240

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

Lambda Antigen Tray™ Mixed Class I & II - 00812117018652

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

  • 00812117018652 ()
LATM20X5P

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

Lambda Antigen Tray™ Mixed Class I - 00812117018645

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

  • 00812117018645 ()
LATM120P

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