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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 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
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

  • 00812117010137 ()
TM144B

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

  • 00812117010113 ()
DR72

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

  • 00812117010090 ()
C722

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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
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
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
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
No Description
CareDx AB
101.708-24u
In Commercial Distribution

  • 07340035507147 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.701-06u
In Commercial Distribution

  • 07340035507048 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.701-24u
In Commercial Distribution

  • 07340035507024 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211049 ()


  • Troponin I IVD, reagent
CARTRIDGE, cTnI
ABBOTT POINT OF CARE INC.
06P23-25
Not in Commercial Distribution

  • 10054749001986 ()
  • 00054749001989 ()
06P23-25

  • Troponin I IVD, reagent
TROPONIN CARTRIDGE
ABBOTT POINT OF CARE INC.
03P90-25
In Commercial Distribution

  • 10054749000187 ()
  • 00054749000180 ()
03P90-25

  • Troponin I IVD, reagent
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls
INSTRUMENTATION LABORATORY COMPANY
0009802116
In Commercial Distribution

  • 08426950497028 ()
0009802116

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, control
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls
INSTRUMENTATION LABORATORY COMPANY
0009802112
In Commercial Distribution

  • 08426950497011 ()
0009802112

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, control
The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS
In Commercial Distribution

  • 10888234500254 ()
PAKPLUS

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
EliA ß2-Glycoprotein I IgM Well
Phadia AB
DECC055330
In Commercial Distribution

  • 07333066010809 ()
  • 07333066014760 ()
DECC055330

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
EliA ß2-Glycoprotein I IgG Well
Phadia AB
DECC055320
In Commercial Distribution

  • 07333066010793 ()
  • 07333066014753 ()
DECC055320

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
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