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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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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)
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)
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)
DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628911
Not in Commercial Distribution

  • 10888234400004 ()
628911

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20301
In Commercial Distribution

  • 10888234102670 ()
800-20301

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
790-20016-RF
In Commercial Distribution

  • 10888234102236 ()
790-20016-RF

  • Microarray analyser IVD, semi-automated
No Description
BIOARRAY SOLUTIONS LTD
790-20016
In Commercial Distribution

  • 10888234102229 ()
790-20016

  • Microarray analyser IVD, semi-automated
No Description
BIOARRAY SOLUTIONS LTD
790-20006-RF
In Commercial Distribution

  • 10888234102212 ()
790-20006-RF

  • Microarray analyser IVD, semi-automated
No Description
BIOARRAY SOLUTIONS LTD
790-20006
In Commercial Distribution

  • 10888234102205 ()
790-20006

  • Microarray analyser IVD, semi-automated
No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution

  • 10888234100836 ()
800-00287

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution

  • 10888234100683 ()
800-00195

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00191
In Commercial Distribution

  • 10888234100621 ()
800-00191

  • Multiple blood group genotyping IVD, reagent
Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0705410
In Commercial Distribution

  • 10888234001812 ()
0705410

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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