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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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Terasaki HLA-B7/40 Supplement Tissue Typing Tray - 00812117010083

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

  • 00812117010083 ()
BS740-72

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

Terasaki HLA-B Locus Supplement Tissue Typing Tray - 00812117010076

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

  • 00812117010076 ()
BS72

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

Terasaki HLA-A Locus Supplement Tissue Typing Tray - 00812117010069

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

  • 00812117010069 ()
AS72

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

Terasaki HLA-ABC Oriental Tissue Typing Tray - 00812117010052

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

  • 00812117010052 ()
OT-72

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

Terasaki HLA-C Locus Tissue Typing Tray - 00812117010045

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

  • 00812117010045 ()
C72

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

Terasaki HLA-ABC Third Tissue Typing Tray - 00812117010038

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

  • 00812117010038 ()
T3-72

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

Terasaki HLA-ABC First Tissue Typing Tray - 00812117010014

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

  • 00812117010014 ()
T1-72

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

ARK™ Methotrexate II Dilution Buffer - 00812101031223

ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator

ARK™ Methotrexate II Control - 00812101031216

ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-02
In Commercial Distribution

  • 00812101031216 ()
5071-0003-02

  • Methotrexate therapeutic drug monitoring IVD, control

ARK™ Methotrexate II Control - 00812101031209

ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-01
In Commercial Distribution

  • 00812101031209 ()
5071-0003-01

  • Methotrexate therapeutic drug monitoring IVD, control
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