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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 TAQ Polymerase - 10888234400134

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
628075
In Commercial Distribution

  • 10888234400134 ()
628075

  • DNA amplification enzyme reagent IVD

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)
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