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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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NOVEOS IgE Calibrator Antibody Pack - 00816879023077

No Description
HYCOR BIOMEDICAL LLC
63180
In Commercial Distribution

  • 00816879023077 ()


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

NOVEOS IgE Calibrator Set - 00816879023015

No Description
HYCOR BIOMEDICAL LLC
63145
Not in Commercial Distribution

  • 00816879023015 ()


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

Hytec EIA Kit - 00816879022308

No Description
HYCOR BIOMEDICAL LLC
74155
Not in Commercial Distribution

  • 00816879022308 ()


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

NOVEOS Fluo Beads - 00816879028881

No Description
HYCOR BIOMEDICAL LLC
K332065-2
In Commercial Distribution

  • 00816879028881 ()


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

NOVEOS Substrate Pack - 00816879028850

No Description
HYCOR BIOMEDICAL LLC
K33218085-4
In Commercial Distribution

  • 00816879028850 ()


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

NOVEOS Conjugate IgE - 00816879028836

No Description
HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


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

NOVEOS Diluent A Kit - 00816879028829

No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


  • 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
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