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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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LIFECODES LSA Class I - 10888234400332

LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
265100IVD
In Commercial Distribution

  • 10888234400332 ()
265100IVD

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

LIFECODES LifeScreen Deluxe - 10888234400318

LIFECODES LifeScreen Deluxe is a qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules
IMMUCOR GTI DIAGNOSTICS, INC.
628215
In Commercial Distribution

  • 10888234400318 ()
628215

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

LIFECODES Class II IDv2 for use with Luminex - 10888234400301

LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

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

LIFECODES Class I ID Typing Kit for use with Luminex - 10888234400295

LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

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

LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with Luminex - 10888234400080

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628927
In Commercial Distribution

  • 10888234400080 ()
628927

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex - 10888234400073

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628925
In Commercial Distribution

  • 10888234400073 ()
628925

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine - 10888234400066

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628923
Not in Commercial Distribution

  • 10888234400066 ()
628923

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex - 10888234400059

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628921
In Commercial Distribution

  • 10888234400059 ()
628921

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex - 10888234400035

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628917
In Commercial Distribution

  • 10888234400035 ()
628917

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B SSO Typing Kit for use with Luminex - 10888234400028

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628915
Not in Commercial Distribution

  • 10888234400028 ()
628915

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)
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