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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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QC Sets and Panels: Helix Elite™ - 70845357042704

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™ - 70845357041363

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

ImmunoCAP Allergen ex2, Animal proteins - 07333066004068

ImmunoCAP Allergen ex2, Animal proteins
Phadia AB
14-4512-01
In Commercial Distribution

  • 07333066004068 ()
14-4512-01

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

ImmunoCAP Allergen k82, Latex - 07333066004051

ImmunoCAP Allergen k82, Latex
Phadia AB
14-4511-01
In Commercial Distribution

  • 07333066004051 ()
14-4511-01

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

ImmunoCAP Allergen m205, Trichophyton rubrum - 07333066003979

ImmunoCAP Allergen m205, Trichophyton rubrum
Phadia AB
14-4483-01
In Commercial Distribution

  • 07333066003979 ()
14-4483-01

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

ImmunoCAP Allergen o1, Cotton, crude fibers - 07333066003962

ImmunoCAP Allergen o1, Cotton, crude fibers
Phadia AB
14-4476-01
In Commercial Distribution

  • 07333066003962 ()
14-4476-01

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

ImmunoCAP Allergen p4, Anisakis - 07333066003955

ImmunoCAP Allergen p4, Anisakis
Phadia AB
14-4475-01
In Commercial Distribution

  • 07333066003955 ()
14-4475-01

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

ImmunoCAP Allergen i8, Moth - 07333066003948

ImmunoCAP Allergen i8, Moth
Phadia AB
14-4474-01
In Commercial Distribution

  • 07333066003948 ()
14-4474-01

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

ImmunoCAP Allergen f61, Sardine, Pilchard - 07333066003931

ImmunoCAP Allergen f61, Sardine, Pilchard
Phadia AB
14-4465-01
In Commercial Distribution

  • 07333066003931 ()
14-4465-01

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

ImmunoCAP Allergen f59, Octopus - 07333066003917

ImmunoCAP Allergen f59, Octopus
Phadia AB
14-4463-01
In Commercial Distribution

  • 07333066003917 ()
14-4463-01

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