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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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ImmunoCAP Allergen e1, Cat dander - 07333066001166

ImmunoCAP Allergen e1, Cat dander
Phadia AB
14-4109-01
In Commercial Distribution

  • 07333066001166 ()
14-4109-01

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

ImmunoCAP Allergen d2, House dust mite - 07333066001159

ImmunoCAP Allergen d2, House dust mite
Phadia AB
14-4108-01
In Commercial Distribution

  • 07333066001159 ()
14-4108-01

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

ImmunoCAP Allergen d1, House dust mite - 07333066001142

ImmunoCAP Allergen d1, House dust mite
Phadia AB
14-4107-01
In Commercial Distribution

  • 07333066001142 ()
14-4107-01

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

ImmunoCAP Allergen m6, Alternaria alternata - 07333066001135

ImmunoCAP Allergen m6, Alternaria alternata
Phadia AB
14-4106-01
In Commercial Distribution

  • 07333066001135 ()
14-4106-01

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

ImmunoCAP Allergen w21, Wall pellitory - 07333066001111

ImmunoCAP Allergen w21, Wall pellitory
Phadia AB
14-4104-01
In Commercial Distribution

  • 07333066001111 ()
14-4104-01

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

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (100ND) - 00813382012185

KIT, OPTIGEN US Environmental 36 (100ND)
Minaris Medical America, Inc.
85268
In Commercial Distribution

  • 00813382012185 ()
85268

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

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
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