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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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A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
E004
Not in Commercial Distribution

  • 00816879021165 ()
74220

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
E003
Not in Commercial Distribution

  • 00816879021158 ()
74219

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
E002
Not in Commercial Distribution

  • 00816879021141 ()
74211

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
E001
Not in Commercial Distribution

  • 00816879021134 ()
74210

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
D002
Not in Commercial Distribution

  • 00816879021127 ()
74202

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
D001
Not in Commercial Distribution

  • 00816879021110 ()
74201

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HYCOR BIOMEDICAL LLC
G009
In Commercial Distribution

  • 00816879029932 ()
8634620Z

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HYCOR BIOMEDICAL LLC
G003
In Commercial Distribution

  • 00816879029925 ()
63280Z

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HYCOR BIOMEDICAL LLC
F002
In Commercial Distribution

  • 00816879029918 ()
63219Z

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HYCOR BIOMEDICAL LLC
F001
In Commercial Distribution

  • 00816879029901 ()
63218Z

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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