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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-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)

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

BioArray Assay Imaging System TM (AIS) 400D - 10888234102236

No Description
BIOARRAY SOLUTIONS LTD
790-20016-RF
In Commercial Distribution

  • 10888234102236 ()
790-20016-RF

  • Microarray analyser IVD, semi-automated

BioArray Assay Imaging System TM (AIS) 400D - 10888234102229

No Description
BIOARRAY SOLUTIONS LTD
790-20016
In Commercial Distribution

  • 10888234102229 ()
790-20016

  • Microarray analyser IVD, semi-automated
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