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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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DonorScreen-HLA® Class I and Class II Additional Reagents - 10888234500186

DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
303456
In Commercial Distribution

  • 10888234500186 ()
303456

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)

LIFECODES® QuikScreen® - 10888234500094

LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)

Dilution Solution - 10888234400769

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515
In Commercial Distribution

  • 10888234400769 ()
628515

  • Buffered sample diluent IVD

Dilution Solution - 10888234400745

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628155
Not in Commercial Distribution

  • 10888234400745 ()
628155

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

Negative Control Serum - 10888234400622

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403887
Not in Commercial Distribution

  • 10888234400622 ()
403887

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

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

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

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

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
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