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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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for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823030
Not in Commercial Distribution

  • 07611969952779 ()
823030

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 6 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823023
Not in Commercial Distribution

  • 07611969952731 ()
823023

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 6 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823020
Not in Commercial Distribution

  • 07611969952717 ()
823020

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
Warming Blanket, Full Body 100 x 195 cm 1.    GENERAL DESCRIPTION ·         PremierPro™ Multi-functional Warming Blankets 2.    CONSTRUCTION ·         Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric ·         Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) ·         White (patient facing) Layer - Perforated to enable passage of air and temperature control ·         Disposable / Single Patient Use ·         Not made with natural rubber latex. 3.    MRI COMPATIBLE ·         Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3821
In Commercial Distribution

  • 10811220031739 ()
  • 00811220031732 ()
3821

  • Blanket warming cabinet, dry-heat
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
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

  • 00812117018638 ()
LATM10X5P

  • 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

  • 00812117018560 ()
LAT1HDS

  • 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

  • 00812117018546 ()
LAT1288S

  • 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

  • 00812117018539 ()
LAT1240S

  • 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

  • 00812117018522 ()
LAT124010

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