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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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Lambda Antigen Tray™ Class I - 2 test tray - 00812117012469

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

Lambda Antigen Tray™ Class I - 1 test tray - 00812117012452

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

Terasaki HLA Class I Asian Dry Tissue Typing Tray - 00812117010175

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

  • 00812117010175 ()
ASN72D

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

Terasaki HLA Class I Dry Tissue Typing Tray - 00812117010168

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

  • 00812117010168 ()
AB72D

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

MMA (Methylmalonic Acid) Level 1 - B800740530

MMA (Methylmalonic Acid) Level 1
UTAK LABORATORIES, INC.
74053
In Commercial Distribution

  • B800740535 ()
  • B800740530 ()

  • Total Volume: 5 Milliliter
74053

  • Methylmalonic acid (MMA) IVD, control

Healgen - 00816490020950

14 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG /pH
Healgen Scientific Limited Liability Company
HCDOAV-1144A3
In Commercial Distribution

  • 20816490020954 ()
  • 10816490020957 ()
  • 00816490020950 ()
HCDOAV-1144A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490020042

13 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-2135
In Commercial Distribution

  • 20816490020046 ()
  • 10816490020049 ()
  • 00816490020042 ()
HCDOAV-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Phosphate Buffered Saline/Citrate Reagent - 00814695020492

FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695020492 ()
PC1-500

  • Cell centrifugation/density gradient separation reagent IVD

HydroMark - 00841911101505

HydroMARK Breast Biopsy Site Marker
DEVICOR MEDICAL PRODUCTS, INC.
4010-03-09-T1
In Commercial Distribution

  • 10841911101502 ()
  • 00841911101505 ()

  • Needle Gauge: 9 Gauge


  • Radiological image marker, implantable

MEDI - 00636257002575

***DISC*JUXTALITE HD 28 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33024017
Not in Commercial Distribution

  • 00636257002575 ()


  • Compression bandaging kit
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