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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 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)

LIFECODES HLA-A SSO Typing Kit - 10888234400004

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)

Carrier Box, ETC, Slide, IVD - 10888234102670

No Description
BIOARRAY SOLUTIONS LTD
800-20301
In Commercial Distribution

  • 10888234102670 ()
800-20301

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable

Precise TypeTM HEA BeadCheck Kit - 10888234102632

No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control

Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate - 10888234102618

No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)

BeadCheck HEA Ref-pB, Bulk and Fill - 10888234102328

No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control

BeadCheck HEA Ref-pA, Bulk and Fill - 10888234102298

No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control

Filled Vial,Negative Control 1mL - 10888234100836

No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution

  • 10888234100836 ()
800-00287

  • Multiple blood group genotyping IVD, reagent

Filled Vial, Clean-up, 330uL - 10888234100621

No Description
BIOARRAY SOLUTIONS LTD
800-00191
In Commercial Distribution

  • 10888234100621 ()
800-00191

  • Multiple blood group genotyping IVD, reagent

ImmuAdd - 10888234000167

ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
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