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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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SeCore™ DRB1 Locus Sequencing Kit - 00814695021727

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021727 ()
5330025

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

SeCore™ C Locus Sequencing Kit - 00814695021710

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021710 ()
5320025

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

SeCore™ B Locus Sequencing Kit - Group Specific Set - 00814695021703

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021703 ()
5310025

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

SeCore™ A Locus Sequencing Kit - 00814695021697

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021697 ()
5300025

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

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND) - 00813382012178

KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND) - 00813382012154

KIT, OPTIGEN US Food 30 (40ND)
Minaris Medical America, Inc.
85167
In Commercial Distribution

  • 00813382012154 ()
85167

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) - 00813382010440

KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) - 00813382010433

KIT, OPTIGEN US Food 25 (100 ND)
Minaris Medical America, Inc.
85082
In Commercial Distribution

  • 00813382010433 ()
85082

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) - 00813382010426

KIT, OPTIGEN US Inhalant 36 (100 ND)
Minaris Medical America, Inc.
85081
In Commercial Distribution

  • 00813382010426 ()
85081

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® US Panel Control Reagent - 00813382010402

KIT, OPTIGEN US Panel Control Reagent
Minaris Medical America, Inc.
80109
In Commercial Distribution

  • 00813382010402 ()
80109

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
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