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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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OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel - 00813382010372

KIT, OPTIGEN US Inhalant 36
Minaris Medical America, Inc.
85063
In Commercial Distribution

  • 00813382010372 ()
85063

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

CLA® Allergen-Specific IgE Assay - Eastern - 00813382010334

Kit, Southern
Minaris Medical America, Inc.
84508
Not in Commercial Distribution

  • 00813382010334 ()
84508

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

CLA® Allergen-Specific IgE Assay - Moderate Food Panel - 00813382010174

KIT, Moderate Food
Minaris Medical America, Inc.
84518
In Commercial Distribution

  • 00813382010174 ()
84518

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

CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel - 00813382010150

KIT, Southwestern Inhalant
Minaris Medical America, Inc.
84509
Not in Commercial Distribution

  • 00813382010150 ()
84509

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

CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel - 00813382010143

KIT, Southeastern Inhalant
Minaris Medical America, Inc.
84507
In Commercial Distribution

  • 00813382010143 ()
84507

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

CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel - 00813382010136

KIT, Pediatric Comprehensive
Minaris Medical America, Inc.
84506
Not in Commercial Distribution

  • 00813382010136 ()
84506

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

CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel - 00813382010129

KIT, Northwestern Inhalant
Minaris Medical America, Inc.
84505
Not in Commercial Distribution

  • 00813382010129 ()
84505

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

CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel - 00813382010112

KIT, Northeastern Inhalant
Minaris Medical America, Inc.
84504
In Commercial Distribution

  • 00813382010112 ()
84504

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

CLA® Allergen-Specific IgE Assay - Eastern - 00813382010105

KIT, Eastern
Minaris Medical America, Inc.
84502
In Commercial Distribution

  • 00813382010105 ()
84502

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

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010075

KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

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