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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 - 10888234400578

For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628221
Not in Commercial Distribution

  • 10888234400578 ()
628221

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

Negative Control Serum - 10888234400547

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628214
Not in Commercial Distribution

  • 10888234400547 ()
628214

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

Positive Control Serum - 10888234400523

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628213
Not in Commercial Distribution

  • 10888234400523 ()
628213

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

LIFECODES Wash Buffer - 10888234400516

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

  • 10888234400516 ()
628211

  • Buffered wash solution IVD

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)

LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex - 10888234400011

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628913
In Commercial Distribution

  • 10888234400011 ()
628913

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