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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 Class I ID Typing Kit for use with Luminex - 10888234400295

LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I 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

LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with Luminex - 10888234400080

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628927
In Commercial Distribution

  • 10888234400080 ()
628927

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

BioArray Assay Imaging System TM (AIS) 400C - 10888234102212

No Description
BIOARRAY SOLUTIONS LTD
790-20006-RF
In Commercial Distribution

  • 10888234102212 ()
790-20006-RF

  • Microarray analyser IVD, semi-automated

Filled Vial,HotStarTaq DNA Polymerase - 10888234100928

No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent

Filled Vial, Lambda Exonuclease - 10888234100683

No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution

  • 10888234100683 ()
800-00195

  • Multiple blood group genotyping IVD, reagent

Filled Vial, HEA 1.2 PCR Mix - 10888234100669

No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent

Filled Vial, eMAPTM Elongation Mix - 10888234100645

No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent

Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides - 10888234100065

No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution

  • 10888234100065 ()
800-20202-08

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

Echo Lumena - 10888234002338

The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
IMMUCOR, INC.
0086998
In Commercial Distribution

  • 10888234002338 ()
0086998

  • Immunohaematology/blood bank analyser IVD
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