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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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Pak2-LE - 10888234500230

Pak2-LE is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK2-LE
Not in Commercial Distribution

  • 10888234500230 ()
PAK2-LE

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)

Positive Control Serum - 10888234400615

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403892
Not in Commercial Distribution

  • 10888234400615 ()
403892

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

Negative Control Serum - 10888234400592

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

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

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

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

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 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 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 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 TAQ Polymerase - 10888234400134

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

  • 10888234400134 ()
628075

  • DNA amplification enzyme reagent IVD
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