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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 Conjugate IgE - 00816879029635

No Description
HYCOR BIOMEDICAL LLC
K332030-2Z
In Commercial Distribution

  • 00816879029635 ()


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

NOVEOS Diluent A Kit - 00816879029628

No Description
HYCOR BIOMEDICAL LLC
K332020-2Z
In Commercial Distribution

  • 00816879029628 ()


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

NOVEOS IgE Calibrator Antibody Pack - 00816879029550

No Description
HYCOR BIOMEDICAL LLC
63180Z
In Commercial Distribution

  • 00816879029550 ()


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

NOVEOS IgE Calibrator Set - 00816879029499

No Description
HYCOR BIOMEDICAL LLC
63125Z
In Commercial Distribution

  • 00816879029499 ()


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

NOVEOS Substrate Pack - 00816879029468

No Description
HYCOR BIOMEDICAL LLC
K33218085-4Z
In Commercial Distribution

  • 00816879029468 ()


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

NOVEOS IgE Calibrator Set - 00816879023251

No Description
HYCOR BIOMEDICAL LLC
63125
In Commercial Distribution

  • 00816879023251 ()


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

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)

CLA® Allergen-Specific IgE Assay - Western Inhalant Panel - 00813382010167

KIT, Western Inhalant
Minaris Medical America, Inc.
84511
Not in Commercial Distribution

  • 00813382010167 ()
84511

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