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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 Wash Buffer - 10888234400516

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628211
In Commercial Distribution

  • 10888234400516 ()
628211

  • Buffered wash solution IVD

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

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
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