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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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Positive Control Serum - 10888234400585

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

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

Conjugate Concentrate - 10888234400561

For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628201
In Commercial Distribution

  • 10888234400561 ()
628201

  • HLA class I & II antigen tissue typing IVD, reagent

Conjugate Concentrate - 10888234400509

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628212
In Commercial Distribution

  • 10888234400509 ()
628212

  • HLA class I & II antigen tissue typing IVD, reagent

LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex - 10888234400479

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628936
In Commercial Distribution

  • 10888234400479 ()
628936

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

LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex - 10888234400462

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628930
In Commercial Distribution

  • 10888234400462 ()
628930

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

LIFECODES MATCH IT!™ DNA Software v1.2 - 10888234400394

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
Not in Commercial Distribution

  • 10888234400394 ()
888623

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

LIFECODES LSA Class II - 10888234400349

LIFECODES LSA Class II 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.
265200IVD
In Commercial Distribution

  • 10888234400349 ()
265200IVD

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

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
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