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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 Rf328, Fig
Phadia AB
14-5244-10
In Commercial Distribution

  • 07333066008998 ()
14-5244-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e221, Allergen component nCan f 3 Dog serum albumin
Phadia AB
14-5241-01
In Commercial Distribution

  • 07333066008943 ()
14-5241-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e220, Allergen component rFel d 2 Cat serum albumin
Phadia AB
14-5240-01
In Commercial Distribution

  • 07333066008929 ()
14-5240-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rf325, Sheep milk
Phadia AB
14-5237-10
In Commercial Distribution

  • 07333066008899 ()
14-5237-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g206, Allergen component rPhl p 2 Timothy
Phadia AB
14-5235-01
In Commercial Distribution

  • 07333066008868 ()
14-5235-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g205, Allergen component rPhl p 1 Timothy
Phadia AB
14-5234-01
In Commercial Distribution

  • 07333066008844 ()
14-5234-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Rare Allergen Re219, Chicken serum proteins
Phadia AB
14-5230-10
In Commercial Distribution

  • 07333066008837 ()
14-5230-10

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

  • 00813382010143 ()
84507

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