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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 fx74, Fish
Phadia AB
14-4827-10
In Commercial Distribution

  • 07333066004402 ()
14-4827-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f245, Egg
Phadia AB
14-4826-01
In Commercial Distribution

  • 07333066004389 ()
14-4826-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen fx73, Meat
Phadia AB
14-4825-01
In Commercial Distribution

  • 07333066004372 ()
14-4825-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
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
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
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
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
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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