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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
W010
Not in Commercial Distribution

  • 00816879021752 ()
74433

  • 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
W009
Not in Commercial Distribution

  • 00816879021745 ()
74432

  • 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
W006
Not in Commercial Distribution

  • 00816879021738 ()
74431

  • 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
M002
Not in Commercial Distribution

  • 00816879021547 ()
74384

  • 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
M001
Not in Commercial Distribution

  • 00816879021530 ()
74383

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Avena sativa
HYCOR BIOMEDICAL LLC
G014
Not in Commercial Distribution

  • 00816879021523 ()
74340

  • 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
G012
Not in Commercial Distribution

  • 00816879021516 ()
74339

  • 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
G013
Not in Commercial Distribution

  • 00816879021509 ()
74338

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Festuca elatior
HYCOR BIOMEDICAL LLC
G004
Not in Commercial Distribution

  • 00816879021493 ()
74337

  • 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
G001
Not in Commercial Distribution

  • 00816879021486 ()
74336

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